TR BAND TRB29-LRG (UDI 00389701011356)Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00389701011356), received between Sep 15, 2016 and Oct 17, 2025 — classified as 17 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (28 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Deflation Problem; Deflation Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: AFTER APPLYING THE TR BAND AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY AREA, THE RECOVERY NURSE NOTICED THAT THE BAND WAS DEFLATED. THE PATIENT WAS NOT BLEEDING, AND THE STAFF APPLIED A BLOOD PRESSURE CUFF ON THE UPPER ARM AND INFLATED IT TO ABOVE SYSTOLIC PRESSURE. THEY REMOVED THE OLD BAND AND APPLIED A NEW ONE. THE PATIENT HAD NO OTHER ISSUES AND WAS DISCHARGED ON THE SAME DAY. PATIENT WAS IN STABLE CONDITION, NO OTHER RELEVANT HISTORY. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 29SEPT2025: THE PROCEDURE WAS A LEFT HEART CATHETERIZATION. THEY STARTED WITH 13 ML OF AIR HOWEVER, WHEN THE PATIENT WENT TO THE RECOVERY AREA THE BAND HAD 10ML OF AIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23331274 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL RECEIVED THE FOLLOWING INFORMATION: BLEEDING WAS OBSERVED UPON INITIAL DEFLATION OF THE TR BAND. THE SITE CONTINUED TO SHOW OOZING AND SWELLING ABOVE THE ACCESS POINT. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. ADDITIONAL INFORMATION WAS RECEIVED ON 18SEP2025: THE BLOOD LOSS WAS LESS THAN 250CC. THE BLEEDING WAS NOTED WHILE THE STAFF WAS DEFLATING THE TR BAND PER PROTOCOL. THE PATIENT WAS TREATED AND RELEASED IN STABLE CONDITION; HOWEVER, THE LENGTH OF STAY WAS INCREASED.

  Patient problems: Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 23310303 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THEY ARE HAVING AN UNKNOWN ISSUE WITH THE TR BAND. ADDITIONAL INFORMATION WAS RECEIVED ON 16SEPT2025: OOZING WAS NOTED IMMEDIATELY UPON ARRIVAL TO CARDIAC PROGRESSIVE CARE UNIT (CPCU), POST PROCEDURE 2 CC OF AIR WAS ADDED. SITE CHECK AT 0930, PATIENT WAS FOUND TO HAVE BLEEDING AND A HEMATOMA. MANUAL PRESSURE WAS HELD AND 2 VASC BANDS WERE APPLIED. ADDITIONAL INFORMATION WAS RECEIVED ON 18SEPT2025: THERE WAS NO BLOOD LOSS GREATER THAN 250CC. THE SIZE OF THE HEMATOMA WAS NOT AVAILABLE. THE BLEEDING WAS NOTED WHILE THE STAFF WAS DEFLATING THE TR BAND PER PROTOCOL. THE PATIENT WAS TREATED AND RELEASED IN STABLE CONDITION; HOWEVER, THE LENGTH OF STAY WAS INCREASED.

  Patient problems: Hematoma

  MAUDE report 23286948 ↗
• MalfunctionJul 10, 2025Gas/Air Leak; Unintended Deflation; Gas/Air Leak; Unintended Deflation

  THE USER FACILITY REPORTED THAT WHEN THE USER WAS ALMOST DONE REMOVING AIR, A SLOW LEAK OCCURRED. THE PATIENT WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI) PATIENT. WHEN THEY WENT TO REMOVE MORE AIR, IT WAS ALL DEFLATED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 25JUN2025: IT WAS UNKNOWN HOW MANY ML'S OF AIR WERE INJECTED INTO THE TR BAND. THE TR BAND STARTED TO DEFLATE ONE-HOUR POST-SURGERY. HEMOSTASIS WAS ACHIEVED BY THE TR BAND. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE PATIENT WAS STABLE. IT WAS UNKNOWN WHERE THE AIR WAS LEAKING FROM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469364 ↗
• MalfunctionJun 19, 2025Gas/Air Leak; Unintended Deflation; Gas/Air Leak; Unintended Deflation

  THE USER FACILITY REPORTED THAT THE TR BAND WAS PLACED ON PATIENT IN NORMAL FASHION. THE SHEATH WAS PULLED, AND HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS TRANSFERRED TO STRETCHER, THE STAFF THEN NOTICED BLOOD LEAKING FROM SITE. A NEW TR BAND WAS APPLIED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO PATIENT INJURY. THE PROCEDURE PERFORMED WAS A HEART CATHETERIZATION. ADDITIONAL INFORMATION WAS RECEIVED ON 23MAY2025: APPROXIMATELY 15MLS OF AIR WERE INJECTED IN EACH TR BAND. THEN APPROXIMATELY FIVE TO SIX MINUTES AFTER FILLING EACH TR BAND PER PROTOCOL BLOOD LEAKAGE WAS NOTED AT THE ENTRY SITE. THEY CONFIRMED THAT THE TR BAND BALLOONS LOST AIR AND DEFLATED. THERE WAS NO DAMAGE NOTED TO EITHER DEVICE. THE PATIENT WAS CONFIRMED TO BE STABLE WITH NO ISSUES AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290862 ↗
• MalfunctionMay 9, 2025Gas/Air Leak; Gas/Air Leak

  THE USER FACILITY REPORTED THAT THE PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED VIA THE RIGHT RADIAL ARTERY. UPON COMPLETION OF THE PROCEDURE, A TR BAND WAS APPLIED, INFLATED, AND THE SHEATH WAS REMOVED. AFTER ADJUSTING THE AIR IN THE BAND AND REMOVING THE SYRINGE, THE PHYSICIAN NOTED THAT THE BALLOONS APPEARED TO BE LOSING AIR AND BLEEDING WAS OCCURRING. THE BAND WAS REPLACED WITH A NEW BAND, AND THERE WERE NO FURTHER ISSUES WITH RECOVERY. BLOOD LOSS WAS LESS THAN 250 CC. NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 21 APR 2025: THE VOLUME OF AIR INJECTED CANNOT BE VERIFIED BECAUSE THE LAB DOES NOT RECORD THE AIR INSERTED INTO THE BAND. DEFLATION WAS IDENTIFIED BY THE PHYSICIAN IMMEDIATELY AFTER REMOVING THE SHEATH AND DISCONNECTING THE SYRINGE. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE PATIENT REMAINED STABLE, WITH NO INJURY AND NO HEMATOMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998064 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW(B)(4). THE EVENT DESCRIPTION STATES: PLACED TR BAND ON PATIENT'S WRIST WHICH WAS LARGE AND ABUNDANCE OF LOOSE TISSUE. WITHIN MINUTES OF APPLICATION, IT WAS FOUND THAT A HEMATOMA WAS FORMING PROXIMAL TO THE BAND. A SECOND TR BAND WAS APPLIED TO PROVIDE ADDITIONAL OCCLUSIVE PRESSURE. THE TEAM DEBRIEF DETERMINED THAT THE PRE-FORMED SHAPE AND DESIGN OF THE TR BAND DOES NOT PROVIDE OPTIMAL HEMOSTASIS FOR CERTAIN PATIENT ARM/WRIST ANATOMIES. THE ORIGINAL INTENDED PROCEDURE WAS A CARDIAC CATHETERIZATION VIA RADIAL ARTERY ACCESS SITE. ADDITIONAL INFORMATION WAS RECEIVED ON 18MAR2025: THERE WAS 7ML'S OF AIR INJECTED INTO THE TR BAND WHEN IT WAS APPLIED. MANUAL PRESSURE WAS APPLIED THEN A VASCBAND WAS APPLIED PROXIMAL TO THE TR BAND. THERE WAS NO INJURY AND OR MEDICAL INTERVENTION REQUIRED DUE TO THE HEMATOMA. THE HEMATOMA WAS TREATED BY MANUAL PRESSURE THEN A VASCBAND WAS APPLIED PROXIMAL TO THE TR BAND. THERE WAS ERYTHEMA, EDEMA, AND PULSE PRESENT. THERE WAS NO BLOOD LOSS. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE PATIENT WAS STABLE.

  Patient problems: Erythema; Hematoma; Swelling/ Edema

  MAUDE report 21765400 ↗
• MalfunctionApr 1, 2025Positioning Problem; Positioning Problem

  THE USER FACILITY REPORTED THAT THE TYPE OF INCIDENT/PROBLEM WAS A MALFUNCTION DURING OR AFTER USE. THE LEVEL OF EFFECT WAS NO APPARENT HARM, BUT IT REACHED THE PATIENT/PERSON AND WAS INCONVENIENT. THE INCIDENT DETAILS ARE AS FOLLOWS: THE PATIENT WAS RECEIVED FROM THE CATHETERIZATION LABORATORY WITH AN OLD TR BAND IN SITU ON THE RIGHT ARM OVER THE ULNAR ACCESS SITE (GREEN TAB ON THE BALLOON). WHILE SETTLING THE PATIENT IN THE ROOM AND ATTACHING MONITORS, THE RIGHT HAND WAS NOTED TO BE DUSKY PURPLE AND SWOLLEN. IMMEDIATE PRESSURE WAS APPLIED BY A CO-WORKER. THE CHARGE NURSE WAS MADE AWARE AND THE INTERVENTIONALIST WAS PAGED. THE INTERVENTIONALIST STATED THAT THE BAND WAS MISPOSITIONED AND NEEDED A SECOND BAND. THE MEDICAL DOCTOR RE-POSITIONED THE BAND. A SECOND BAND WAS OBTAINED FROM THE CATHETERIZATION LABORATORY BY THE WRITER. THE INTERVENTIONALIST WAS GONE, AND MANUAL PRESSURE WAS STILL BEING APPLIED. NURSES FROM THE CATHETERIZATION LABORATORY CAME INTO RE-APPLY THE SECOND TR BAND. ADDITIONAL INFORMATION AND IMPACT OF THE INCIDENT INCLUDE THAT MANUAL PRESSURE WAS APPLIED TO THE ARM AND A SECOND TR BAND WAS APPLIED. MANUAL PRESSURE WAS HELD FOR A TOTAL OF 1.5 HOURS. THE PATIENT WA

  Patient problems: Swelling/ Edema

  MAUDE report 21741808 ↗
• InjuryNov 27, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WHEN THE TR BAND WAS INFLATED, IT DID NOT STAY INFLATED AND CAUSED A HEMATOMA UNDER THE PATIENT'S SKIN. ADDITIONAL INFORMATION WAS RECEIVED ON 31OCT2024: THE PROCEDURE FOR THE PATIENT PRIOR TO THE USE OF THE TR BAND WAS A HEART CATHETERIZATION. APPROXIMATELY 10-14MLS OF AIR WERE INJECTED INTO THE TR BAND. SHEATH AND CATHETERS WERE USED DURING THE HEART CATHETERIZATION PROCEDURE. THE TR BAND LOST AIR APPROXIMATELY THREE MINUTES AFTER THE INITIAL INFLATION. HEMOSTASIS WAS ACHIEVED BY USING A TR BAND FROM ANOTHER LOT NUMBER, THE INITIAL TR BAND WAS REMOVED MY HOLDING MANUAL COMPRESSION AND THEN APPLYING THE NEW BAND. THEY TREATED THE HEMATOMA WITH COMPRESSION AT THE SITE AND MAY HAVE ADDED PROTAMINE. THE SIZE OF THE HEMATOMA WAS SMALL SINCE IT WAS NOTED RIGHT AWAY, THERE WAS ONLY MINOR SWELLING. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE PATIENT WAS STABLE.

  Patient problems: Hematoma

  MAUDE report 20800171 ↗
• MalfunctionSep 20, 2024Gas/Air Leak; Gas/Air Leak

  THE USER FACILITY REPORTED THAT A NURSE REPORTED THAT AT THE ONE-HOUR MARK, WHEN SHE WENT TO REMOVE THE AIR POST-LEFT HEART CORONARY CATHETERIZATION, SHE FOUND THAT THE INVOLVED TR BAND BALLOONS HAD ALREADY DEFLATED. OUT OF CURIOSITY, SHE TRIED TO REFILL THE BAND WITH AIR AFTER REMOVING IT FROM THE PATIENT AND DISCOVERED A SLOW LEAK. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THERE IS NO DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY OR THE NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 29 AUG 2024: WHEN THE TR BAND WAS APPLIED, 15ML OF AIR WAS INJECTED. NO ADDITIONAL DEVICES WERE USED AT THE ACCESS SITE. THE PATIENT IS STABLE. THE TR BAND WAS NOTED TO HAVE NO AIR IN IT ONE-HOUR POST-PROCEDURE, JUST AS THE NURSE WAS ABOUT TO START REMOVING AIR FROM THE BAND. THE TR BAND WAS LEFT ON THE PATIENT UNINFLATED AND REMOVED TWO HOURS AFTER THE INITIAL APPLICATION. THE SAMPLE IS INFECTIOUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20274925 ↗
• MalfunctionSep 13, 2024Deflation Problem; Deflation Problem

  THE USER FACILITY REPORTED THAT THE TR BAND INVOLVED BALLOON DEFLATED SHORTLY AFTER 15CC OF AIR WAS INTRODUCED. A NEW BAND WAS PLACED SAFELY, AND THE PATIENT IS FINE. THE PROCEDURE CONDUCTED WAS A HEART CATHETERIZATION. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION. THERE IS NO DIRECT CLAIM THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO A PATIENT INJURY OR THE NEED FOR MEDICAL INTERVENTION. THE PATIENT'S PRE-PROCEDURAL CONDITION INCLUDED CHEST PAINS. ADDITIONAL INFORMATION WAS RECEIVED ON 16 AUG 2024: A6 FRENCH & A 6F SLENDER DEVICE WERE USED IN THE ACCESS SITE. IT WAS A TANG FROM TRAUMA. THERE WAS NO OTHER EXPLANATION TO WHY THE DEVICE COULD NOT HOLD THE AIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20214198 ↗
• InjurySep 5, 2024Unintended Deflation; Unintended Deflation

  THE USER FACILITY REPORTED THAT THE PROCEDURE PERFORMED WAS A CORONARY PERCUTANEOUS CORONARY INTERVENTION (PCI) VIA RIGHT RADIAL. AT END OF PROCEDURE, THE PHYSICIAN PLACED THE TR BAND AND INFLATED THE DEVICE USING THE PROVIDED SYRINGE. INTRODUCER SHEATH WAS REMOVED, AND THE BAND WAS TITRATED TO APPROPRIATE AMOUNT OF AIR IN BALLOONS. UPON REMOVAL OF SYRINGE, THE BALLOONS IMMEDIATELY DEFLATED, AND BLEEDING OCCURRED. AIR WAS REINSERTED INTO BAND; HOWEVER, IT WOULD NOT HOLD. THE BAND WAS REMOVED, AND ANOTHER BAND WAS APPLIED. A SMALL HEMATOMA FORMED WHICH WAS TREATED. NO SURGICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 15AUG2024: OTHER DEVICES USED IN THE ACCESS SITE WAS A 6 FRENCH TERUMO R/OII SHEATH. NO TREATMENT WAS REQUIRED FOR THE HEMATOMA. THE HEMATOMA DID NOT EXPAND FURTHER ONCE NEW ANGIO-SEAL WAS DEPLOYED. JUST MONITORED SITE FOR EXPANSION. THE ACTUAL SIZE OF THE HEMATOMA WAS NOT MEASURED, IT WAS INDICATED AS SMALL. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE PATIENT WAS IN STABLE CONDITION, AND THERE WERE ADDITIONAL ISSUES WITH RECOVERY.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20146769 ↗
• MalfunctionJul 10, 2024Deflation Problem; Deflation Problem

  THE USER FACILITY REPORTED THAT THE PROCEDURE PERFORMED WAS A CORONARY PERCUTANEOUS CORONARY INTERVENTION (PCI) VIA RIGHT RADIAL ACCESS. AT END OF THE PROCEDURE, THE PHYSICIAN CLEANED THE SITE AND APPLIED A LARGE TR BAND. THE BAND WAS INFLATED, AND INTRODUCER SHEATH WAS REMOVED. UPON REMOVAL OF THE BAND SYRINGE, THE BALLOONS APPEARED TO IMMEDIATELY DEFLATE, AND BLEEDING STARTED. AN ATTEMPT WAS MADE TO REINFLATE BALLOONS; HOWEVER, THEY WOULD NOT HOLD AIR. MANUAL PRESSURE WAS HELD, AND A NEW TR BAND WAS APPLIED AND INFLATED WITHOUT ISSUE. THE BLOOD LOSS WAS LESS THAN 250CC. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 20JUN2024: THE KAB DID NOT RECORD THE AMOUNT OF AIR IN THE TR BAND. A 6 FRENCH GLIDESHEATH SLENDER WAS USED IN THE ACCESS SITE. THE TR-BAND WAS NOTED TO BE LOSING AIR IMMEDIATELY AFTER REMOVING THE SYRINGE FROM INITIAL INFLATION, BAND LOST AIR AND BLEEDING WAS NOTICED. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE PATIENT WAS STABLE, AND R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19712764 ↗
• MalfunctionJun 15, 2024Gas/Air Leak; Gas/Air Leak

  THE USER FACILITY REPORTED THAT THE INVOLVED TR BAND WAS INFLATED FOR HEMOSTASIS AT THE END OF THE PROCEDURE, BUT IT COMPLETELY LOST PRESSURE TWO MINUTES LATER WHILE THE PATIENT WAS RESTING COMFORTABLY ON THE CART. THE SYRINGE WAS RECONNECTED AND REFILLED; HOWEVER, UPON REMOVAL OF THE SYRINGE, THE BAND IMMEDIATELY LOST ALL AIR AGAIN. THE PROCEDURE PERFORMED WAS A LEFT HEART CATHETERIZATION (LHC). BLOOD LOSS WAS LESS THAN 250CC'S. ON 05/20/2024, ADDITIONAL INFORMATION WAS PROVIDED. ANOTHER TR-BAND WAS UTILIZED. THE PATIENT'S CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19544600 ↗
• MalfunctionApr 24, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE TR BAND BALLOON LOST AIR ALMOST IMMEDIATELY AFTER INFLATION. THE BAND WAS REPLACED WITH A NEW BAND AND PATENT HEMOSTASIS WAS ACHIEVED. THERE WAS NO HEMATOMA. UPON FURTHER INVESTIGATION AFTER THE PATIENT WAS CARED FOR THE TECH ATTEMPTED TO INFLATE THE DEFECTIVE BAND AT THE BACK TABLE AND IT FAILED TWO TIMES. ON THE 3RD ATTEMPT IT HELD AIR. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 15APR2024: THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE TECH MANIPULATED AND TESTED THE DEVICE AFTER THE PATIENT WAS CARED FOR AND MOVED FROM THE PROCEDURE TABLE TO BE TAKEN TO RECOVERY. NO PATIENT INVOLVEMENT DURING THE SUBSEQUENT DEVICE MANIPULATION AND TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174599 ↗
• MalfunctionApr 18, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE TR BAND WAS PLACED FOR HEMOSTASIS, PER PROTOCOL, WITH NO VARIATIONS OF NOTE. THIRTY-FIVE MINUTES AFTER PLACEMENT, THE PATIENT COMPLAINED OF ENGORGEMENT OF RIGHT FOREARM AND HAND, NURSE ARRIVED TO FIND THE TR BAND WAS COMPLETELY VOID OF AIR. THEY ATTEMPTED TO RE-INFLATE THE TR BAND, HOWEVER THE BAND IMMEDIATELY DEFLATED. ALTERNATIVE BANDS WERE APPLIED IN ATTEMPT TO REGAIN HEMOSTASIS. COMPRESSION BANDAGES WERE APPLIED TO THE HAND AND FOREARM IN ATTEMPT TO AVOID THIRD SPACING. THE PROCEDURE FOR THE PATIENT WAS A DIAGNOSTIC RIGHT HEART CATHETERIZATION VIA 6FR RADIAL ACCESS. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133345 ↗
• MalfunctionApr 6, 2024Deflation Problem; Deflation Problem

  THE USER FACILITY REPORTED THAT THE BALLOON ON THE TR BAND WAS LEAKING. THEY THEN HAD TO HAVE SOMEONE HOLD PRESSURE AND PUT ON A NEW TR BAND DUE TO THE RADIAL ARTERY BLEEDING FROM THE FIRST BALLOON NOT HOLDING PRESSURE. THERE WAS NO PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION REQUIRED. NO DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19056602 ↗
• MalfunctionMar 2, 2024Gas/Air Leak; Gas/Air Leak

  THE USER FACILITY REPORTED THAT POST PERCUTANEOUS CORONARY INTERVENTION (PCI), A TR BAND WAS PLACED TO CLOSE THE RADIAL ARTERY. IT WAS REPORTED THAT THE SEAL ON THE ONE-WAY VALVE WAS LEAKING, AND THE BAND WAS NOT ABLE TO HOLD AIR. THE TECH GRABBED ANOTHER TR BAND AND WAS ABLE TO ACHIEVE HEMOSTASIS WITH THE SECOND TR BAND. THERE WAS NO HARM TO THE PATIENT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. NO PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THE EVENT OCCURRED INTRA-OPERATIVE. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 23 FEB 2024: 15 ML'S OF AIR WAS INJECTED INTO THE SYRINGE. THERE WAS A 6 FR GLIDE SHEATH IN THE RIGHT RADIAL ARTERY. TR BAND LOST AIR AS SOON AS THE SYRINGE WAS DISCONNECTED FROM TR BAND. THERE WAS NO NOTICEABLE DAMAGE TO THE BAND. THE PATIENT WAS STABLE, HELD MANUAL PRESSURE AND APPLIED A DIFFERENT TR BAND TO THE SITE. AFTER REPLACING THE TR BAND, AIR WAS INJECTED INTO BAND WHILE UNDER THE SALINE. THE BAND STAYED INFLATED UNTIL DISCONNECTING THE SYRINGE AND AIR CAME BACK THROUGH THE VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18823253 ↗
• MalfunctionFeb 26, 2024Deflation Problem; Deflation Problem

  THE USER FACILITY REPORTED THAT THE DOCTOR FINISHED A LEFT HEART CATH WITH INTERVENTION. HE PLACED THE LARGE TR BAND ON CORRECTLY AND ACHIEVED PATENT HEMOSTASIS. AFTER BREAKING SCRUB, THE TECH NOTIFIED THAT THE SITE WAS OOZING. SO, THE TECH PLACED 5CC'S OF AIR BACK INTO THE BAND AND PATENT HEMOSTASIS WAS ACHIEVED AGAIN. AFTER A MIN OR SO THE TECH NOTICED THE SITE OOZING AGAIN, SO THE TR BAND WAS REMOVED, AND A VASC BAND WAS PLACED. A GLIDESHEATH (60-1060) WAS THE SHEATH THEY HAD IN PLACED BEFORE PLACING THE TR BAND. THE DOCTOR STATED THAT THE BLOOD LOSS WAS VERY MINIMAL. THE PATIENT HAD A HISTORY OF CHEST PAINS. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THERE WAS NO DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 29JAN2024: THERE WAS 15ML'S OF AIR INJECTED INTO THE TR BAND WHEN IT WAS APPLIED. APPROXIMATELY 45 SECONDS AFTER IT WAS NOTICED TO BE LOSING AIR. THERE WAS NO NOTICEABLE DAMAGE TO THE BAND. THE PATIENT DID FINE. THEY SWAPPED TO A COMPETITIVE BAND.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18777066 ↗
• MalfunctionFeb 23, 2024Deflation Problem; Deflation Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED TR BAND WAS PLACED ON THE PATIENT AND WHEN THEY WENT BACK TO MOVE PATIENT THE TR BAND HAD LOST ALL AIR AND PATIENT WAS BLEEDING DUE TO LOSS OF AIR. THE PROCEDURE PERFORMED WAS A DIAGNOSTIC. THE EVENT OCCURRED POST-OPERATIVE. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 08 FEB 2024: THERE WAS 13 MLS OF AIR INJECTED INTO THE TR BAND WHEN IT WAS APPLIED. A SECOND TR BAND WAS USED TO ACHIEVE HEMOSTASIS. AFTER INITIAL INFLATION, THE TR-BAND WAS NOTED TO BE LOSING AIR WITHIN FIVE (5) MINUTES. THERE WAS NO PATIENT INJURY AS A RESULT OF THE DEFLATION. THERE WAS 5ML OF BLOOD LOSS. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE PATIENT WAS STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18769029 ↗
• MalfunctionFeb 18, 2024Inflation Problem; Inflation Problem

  THE USER FACILITY REPORTED THAT THEY ARE HAVING ISSUES GETTING AIR INTO THE TR BAND. THEY BELIEVE THE ISSUE IS WITH THE TIP OF THE SYRINGE NOT SEATING PROPERLY IN THE BAND PORT. THERE WAS NO BLOOD LOSS. THERE WAS NO PATIENT INJURY AND/OR REQUIRED MEDICAL OR SURGICAL INTERVENTION. THE EVENT OCCURRED AFTER THE PATIENT'S HEART CATHETERIZATION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 25JAN2024: 18 ML'S OF AIR WERE INJECTED INTO THE TR BAND WHEN IT WAS APPLIED. A GLIDESHEATH WAS THE OTHER DEVICE USED AT ACCESS SITE. HOLDING AIR WAS NOT THE ISSUE THE ISSUE WAS GETTING AIR INTO THE TR BAND. IT APPEARED THAT THEY COULD NOT GET A GOOD SEAL ON THE SYRINGE TIP TO THE BALLOON PORT. ONCE AIR WAS IN THE TR BAND IT HELD THE AIR. THEY USED A SECOND TR BAND WHEN THE ISSUE OCCURRED. THERE WAS NO INJURY OR HEMATOMA DUE TO THE ISSUE. NO NOTICEABLE DAMAGE TO THE DEVICE. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18728687 ↗
• MalfunctionFeb 16, 2024Gas/Air Leak; Unintended Deflation; Gas/Air Leak; Unintended Deflation

  THE USER FACILITY REPORTED THAT THE DOCTOR HAD A TR BAND THAT DEFLATED AFTER BEING FILLED UP WITH AIR. ADDITIONAL INFORMATION WAS RECEIVED ON 23JAN2024: THE PATIENT PROCEDURE WAS A HEART CATHETERIZATION. THERE WERE 15ML'S OF AIR INJECTED TO THE TR BAND WHEN IT WAS APPLIED. A GLIDESHEATH SLENDER WAS USED IN THE ACCESS SITE. THE TR BAND WAS NOTED TO BE LOSING AIR WITHIN ONE MINUTE OF BEING INFLATED. HEMOSTASIS WAS ACHIEVED BY USING A SECOND TR BAND. THERE WAS NO PATIENT INJURY. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO NOTICEABLE DAMAGE TO THE TR BAND. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727948 ↗
• MalfunctionDec 21, 2023Deflation Problem; Deflation Problem

  THE USER FACILITY REPORTED THAT FOLLOWING A LEFT HEART CATH FROM THE RIGHT RADIAL, CASE COMPLETED WITH A TR BAND APPLIED. THE FIRST TR BAND POSITIONED AND INFLATED, DID NOT HOLD AIR. THE SECOND NEW TR BAND PLACED SUCCESSFULLY WITH NO PATIENT ISSUES. THE EVENT OCCURRED POST-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 08 DEC 2023: THE PROCEDURE WAS A LEFT HEART CATHETERIZATION. THERE WAS 15 ML'S OF AIR INJECTED INTO THE TR BAND WHEN IT WAS APPLIED. THE TR BAND STARTED TO DEFLATE RIGHT AFTER THE PROCEDURE. THE DEVICE WAS NOT MANIPULATED BEFORE USE IN ANY WAY PRE-USE OR DURING STORAGE. THE PRODUCT PRIOR TO USE IS STORED IN DARK SHELVING. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE PATIENT IS STABLE. A SLENDER 5F TIG WAS USED WITH THE TR BAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18380253 ↗
• InjuryDec 2, 2023Device Slipped; Device Slipped

  THE USER FACILITY REPORTED THAT THE TR BAND REGULAR WAS APPLIED TO RIGHT WRIST OF PATIENT AFTER DIAGNOSTIC LEFT HEART CATHETERIZATION (LHC). THE PATIENT WAS SENT BACK TO RECOVERY WITH NO ISSUES. THE RECOVERY NURSE NOTICED LARGE FOREARM HEMATOMA FORMATION AFTER PATIENT WAS IN RECOVERY FOR APPROXIMATELY 30MINS. THE NURSE HAD NOTICED THE TR BAND HAD MIGRATED OFF THE ACCESS SITE. SHE THEN ATTEMPTED A SECOND TR BAND ON TOP OF THE HEMATOMA WHICH DID NOT HELP SO PRESSURE CUFF WAS APPLIED. SECOND TR BAND PLACEMENT ON HEMATOMA AND PRESSURE CUFF. THEY WERE ABLE TO GAIN CONTROL OF THE HEMATOMA AND PATIENT RECOVERED WITH NO ISSUES. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Hematoma

  MAUDE report 18253428 ↗
• InjuryDec 2, 2023Device Slipped; Device Slipped

  THE USER FACILITY REPORTED THAT THE TR BAND LARGE WAS APPLIED TO RIGHT WRIST OF PATIENT AFTER DIAGNOSTIC LEFT HEART CATHETERIZATION (LHC). THE RADIOLOGY TECH WHO PLACED THE TR BAND NOTICED A SMALL HEMATOMA FORMING AFTER PLACING THE BAND ON THE PATIENTS WRIST AND ATTEMPTED TO ADJUST THE BAND WITH ASSISTANCE FROM ANOTHER TECH. THEY WERE ABLE TO HANDLE THE LOCAL HEMATOMA BEFORE PATIENT WAS SENT BACK TO RECOVERY. THE PATIENT RECOVERED WITH NO ISSUES. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Hematoma

  MAUDE report 18253427 ↗