TREK™ 1012276-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08717648138584), received between Aug 18, 2017 and Mar 14, 2025 — classified as 2 deaths, 14 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Separation” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE 3.50X20MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE NOTED DUE TO INTERACTIONS WITH THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 14 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606834 ↗
• MalfunctionMay 20, 2024Deflation Problem; Failure to Fold; Deflation Problem; Failure to Fold

  IT WAS THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 3.5X20MM TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN A PROCEDURE AND THE BALLOON WAS NOTED TO HAVE AN ISSUE RE-WRAPPING; HOWEVER, THE BALLOON EVENTUALLY ABLE TO BE DEFLATED. THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354761 ↗
• InjuryMay 2, 2024Material Separation; Failure to Advance; Difficult to Advance; Failure to Deflate; Material Separation; Failure to Advance; Difficult to Advance; Failure to Deflate

  MEDWATCH # MW5153100 RECEIVED WHICH STATES: BALLOON BROKE OFF DURING PERCUTANEOUS CORONARY INTERVENTION WITH DR (B)(6). BALLOON WAS SUCCESSFULLY RECOVERED AND REMOVED FROM BODY. FOLLOWING RECEIPT OF THE MEDWATCH, IT WAS REPORTED THAT THIS WAS A REVERSE CONTROLLED ANTEGRADE AND RETROGRADE TRACKING (REVERSE CART) PROCEDURE. A REPEATED EXTERNAL CAP CRUSH WAS PERFORMED WITH AN ATTEMPTED ¿OPEN SESAME¿ TECHNIQUE, WITH THE BALLOON ADVANCED RETROGRADE TO DILATE THE RIGHT POSTEROLATERAL ARTERY / RIGHT POSTERIOR DESCENDING ARTERY (RPL / RPDA), BUT THE TREK BDC WAS UNABLE TO REACH TO TARGET SITE DUE TO THE PATIENT ANATOMY. THE 3.5 X 20 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE MID/DISTAL RIGHT CORONARY ARTERY (RCA); HOWEVER, UPON WITHDRAWAL WITHOUT RESISTANCE, THE SHAFT OF THE BDC WAS NOTED TO BE BROKEN, WITH THE BALLOON PORTION SEPARATED AND REMAINING IN THE PROXIMAL RCA. A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE AND A NON-ABBOTT GUIDE WIRE WERE ADVANCED PAST THE BALLOON AND ELECTROCAUTERIZATION WAS ATTEMPTED WITH A NON-ABBOTT DEVICE; HOWEVER, THIS WAS UNABLE TO DEFLATE THE BALLOON. A NON-ABBOTT SNARE DEVICE WAS ADVANCED AND WAS ABLE TO SNARE THE PROXIMAL EDGE OF THE BALLOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234793 ↗
• InjuryApr 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.5X20MM TREK RX BALLOON DILATATION CATHETER (BDC) SHAFT BROKE OFF INSIDE THE ANATOMY. IT IS UNKNOWN IF INTERVENTION WAS PERFORMED TO REMOVE OR EMBED THE SEPARATED PORTION. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19208962 ↗
• InjuryDec 7, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY AND THE PROXIMAL CIRCUMFLEX (PCX). THE 3.5X20MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PLACED IN THE PCX AND A XIENCE SKYPOINT STENT WAS PLACED IN THE PLAD WITHOUT RESISTANCE SIMULTANEOUSLY. THE STENT WAS IMPLANTED AND THE BALLOON WAS INFLATED AFTER TO PROTECT THE PCX THE SDS WAS REMOVED. THERE WAS RESISTANCE WHEN THE BDC WAS ATTEMPTED TO BE REMOVED FULLY DEFLATED AND THERE WAS NO EXTRA FORCE APPLIED, HOWEVER, THE TIP OF THE BALLOON SEPARATED AND WAS STUCK INSIDE THE GUIDE CATHETER. THE PHYSICIAN ATTEMPTED TO USE OTHER BALLOONS TO REMOVE THE STUCK BALLOON FROM THE GUIDE CATHETER BY INFLATING THEM AND TRYING TO CATCH THE DISCONNECTED BALLOON AND DRAG IT OUT. HOWEVER, THAT STRATEGY WAS NOT SUCCESSFUL. SO HE REMOVED ALL GUIDE WIRES AND THE GUIDE CATHETER FROM THE ANATOMY AND RESTARTED THE PROCEDURE WITH A NEW GUIDE WIRE AND REWIRED THE PATIENT. AN NC TREK WAS USED TO POST-DILATE THE IMPLANTED STENT. ANOTHER STENT WAS IMPLANTED IN THE DISTAL LEFT MAIN AND PROCEDURE WAS FINISHED. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287967 ↗
• InjuryNov 21, 2023Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA). THREE XIENCE STENTS WERE IMPLANTED AND A 3.5X20MM TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION; HOWEVER, WHILE CONTINUING THE PROCEDURE IT WAS OBSERVED THROUGH ANGIOGRAPHY THAT THE DISTAL TIP OF THE BALLOON HAD SEPARATED AND WAS INSIDE THE RCA. THE SEPARATED PORTION WAS SUCCESSFULLY SNARED, BUT NOTED TO TAKE 30 MINUTES TO SNARE. IT WAS NOTED THAT THE BDC WAS NOT SOAKED PRIOR TO USE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185402 ↗
• MalfunctionApr 17, 2023Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 80% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.50X20MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE FROM THE ANATOMY AND USED WITHOUT ISSUE. THE BDC WAS REMOVED WITH SLIGHT RESISTANCE FROM THE ANATOMY WHEN THE SHAFT OF THE DEVICE SEPARATED IN THE GUIDE CATHETER (GC). ALL THE SEPARATED SEGMENTS WERE REMOVED INSIDE OF THE GUIDE CATHETER, NO PART OF THE DEVICE WAS LEFT INSIDE OF THE ANATOMY. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16752598 ↗
• MalfunctionFeb 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID RIGHT CORONARY ARTERY THAT WAS MODERATELY TORTUOUS. DURING ADVANCEMENT ON THE WIRE, THE SHAFT OF THE 3.5X20MM TREK BALLOON DILATATION CATHETER (BDC) BROKE IN TWO PIECES, WITH THE BREAK OUTSIDE THE ANATOMY, AND WAS EASILY REMOVED, WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433116 ↗
• MalfunctionJan 16, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A STENT THROMBOSIS IN THE MID RIGHT CORONARY ARTERY (RCA) WITHOUT CALCIFICATION AND WITHOUT TORTUOSITY. THE 3.5X20MM NC TREK RX BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT AND WAS USED TO DILATE THE THROMBUS. HOWEVER, THE TREK BALLOON GOT CAUGHT ON THE TIP OF THE GUIDE CATHETER DURING REMOVAL AND IT WAS THEN DECIDED TO SIMPLY WITHDRAW ALL DEVICES ALTOGETHER. NOTHING REMAINED IN THE PATIENT. THE PROCEDURE WAS RE-STARTED AND REWIRED AND COMPLETED. HOURS LATER THE SAME DAY, THE PATIENT DIED. PER THE PHYSICIAN THE TREK BALLOON DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH IN ANY WAY AND THE STENT THROMBOSIS WAS THE CAUSE OF DEATH. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16179169 ↗
• MalfunctionOct 11, 2022Deflation Problem; Difficult to Remove; Material Separation; Deflation Problem; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 95% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 3.5X20MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND PERFORMED POST-DILATATION WITHOUT ISSUE; HOWEVER, THE BALLOON DID NOT COMPLETELY DEFLATE. THE BDC WAS SAFELY CAPTURED IN THE GUIDE CATHETER FOR REMOVAL, BUT DURING REMOVAL, THE CATHETER OF THE BDC SEPARATED, WITH THE SEPARATED BALLOON PORTION REMAINING IN THE GUIDE CATHETER. THE GUIDE CATHETER AND THE SEPARATED SEGMENT WERE REMOVED FROM THE ANATOMY WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15584500 ↗
• InjuryOct 10, 2022Failure to Fold; Difficult to Remove; Material Separation; Failure to Fold; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CHRONICALLY TOTALLY OCCLUDED LESION IN THE PROXIMAL CIRCUMFLEX ARTERY (CX). THE PATIENT PRESENTED WITH AN ACUTE ST-ELEVATION MYOCARDIAL INFARCTION. AN UNSPECIFIED GUIDE WIRE WAS ADVANCED AND A 3.5X20MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR PRE-DILATATION; HOWEVER, WHEN THE BALLOON WAS DEFLATED WITHOUT ISSUES THE BALLOON DID NOT REWRAP. AN ATTEMPT TO REMOVE THE BDC WAS MADE, BUT RESISTANCE WITH THE GUIDE CATHETER WAS FELT. THE BDC WAS ABLE TO BE PULLED INTO THE GUIDE CATHETER, BUT THE BALLOON SEPARATED IN THE GUIDE CATHETER. THE BDC, SEPARATED BALLOON, AND GUIDE CATHETER WERE REMOVED AS A UNIT. AFTER REMOVAL OF THE DEVICES, ANGIOGRAPHY IN THE LEFT MAIN WAS DONE AND IT WAS NOTED THAT THE THROMBUS (OCCLUSION) IN THE PROXIMAL CX HAD SHIFTED TO THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) BIFURCATION OF THE CX WHILE STILL ALSO REMAINING IN THE CX. WHILE NOTING THE THROMBUS SHIFT A DISSECTION IN THE CX WAS ALSO NOTED. THE LESION WAS RE-WIRED AND AN UNSPECIFIED XIENCE STENT WAS DEPLOYED TO SUCCESSFULLY TREAT THE DISSECTION AND THROMBUS SHIFT. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNI

  Patient problems: Embolism/Embolus; Vascular Dissection

  MAUDE report 15574159 ↗
• InjuryAug 2, 2022Difficult to Remove; Material Separation; Failure to Deflate; Difficult to Remove; Material Separation; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY (RCA) AND THE DISTAL RCA. THE PATIENT HAD TWO UNSPECIFIED XIENCE SKYPOINT STENTS IMPLANTED IN (B)(6) OF 2022. A 2.5X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS USED TO PRE-DILATE BETWEEN THE TWO STENTS. SLOW DEFLATION OF THE BDC WAS NOTED, BUT HAD NO FURTHER ISSUES AND WAS REMOVED SUCCESSFULLY. OPTICAL COHERENCE TOMOGRAPHY (OCT) CONFIRMED THERE WAS A GAP BETWEEN THE TWO PREVIOUSLY IMPLANTED STENTS AND A 4.0X12MM XIENCE SKYPOINT STENT WAS DEPLOYED SUCCESSFULLY WITH SLOW DEFLATION OF THE DEVICE NOTED; HOWEVER, THE STENT DELIVERY SYSTEM WAS REMOVED SUCCESSFULLY. A 4.0X38MM XIENCE SKYPOINT STENT WAS ATTEMPTED TO BE IMPLANTED PROXIMALLY FROM THE PREVIOUSLY IMPLANTED XIENCE SKYPOINT IN JANUARY; HOWEVER, FAILED TO BE IMPLANTED AS INTERACTION WITH THE PREVIOUSLY IMPLANTED STENT WAS FELT. THE 3.5X20MM TREK BALLOON DILATATION CATHETER WAS ADVANCED, THEN INFLATED TWICE TO 12 AND 10 ATMOSPHERES. THE PHYSICIAN ATTEMPTED THREE TIMES TO PULL NEGATIVE, BUT THE BDC WOULD NOT DEFLATE. IT WAS DECIDED TO REMOVE THE BDC WITH THE ENTIRE SYSTEM AS ONE UNIT. DURING REMOVAL THE SHAFT SEPARATED AND BECAME LODGED IN THE ELBOW A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15151574 ↗
• InjurySep 17, 2021Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, 90% STENOSED, HEAVILY CALCIFIED AND HEAVILY TORTUOUS VESSEL IN THE LEFT CIRCUMFLEX (LCX) ARTERY. THE 3.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE NOTED WITH THE LESION. THE TREK BDC WAS USED FOR PRE-DILATATION, HOWEVER, THE BDC SEPARATED AT THE DISTAL PORTION BEFORE THE BALLOON. THERE WAS SOME RESISTANCE WITH THE ANATOMY DURING REMOVAL. THE DEVICE WAS RETRIEVED FROM THE VESSEL WITH A BALLOON ANCHOR. A 3.5X20MM NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487955 ↗
• MalfunctionSep 8, 2021Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS, 80% STENOSED, DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.5X20MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED TO 12 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED AND ANOTHER SAME SIZED BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443193 ↗
• MalfunctionAug 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATE TO SEVERELY [HEAVILY] CALCIFIED LESION IN THE LEFT CORONARY ARTERY. THE 3.5X20MM TREK RX BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT; HOWEVER, THE BALLOON RUPTURED ON THE FIRST INFLATION AT 14 ATMOSPHERES (ATMS). ANOTHER SAME SIZE TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389279 ↗
• InjuryApr 5, 2021Deflation Problem; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY. A 3.5X20MM TREK BALLOON WAS NOT AIR ASPIRATED OUTSIDE THE ANATOMY PRIOR TO USE. THE BALLOON WAS THEN ADVANCED TO THE LESION AND INFLATED TWICE (FIRST TIME 16ATMOSPHERES (ATM) AND SECOND TIME 20ATM) WITHOUT ISSUE. THE BALLOON WAS HELD NEGATIVE FOR 10 SECONDS TO DEFLATE, HOWEVER IT COULD ONLY BE PARTIALLY DEFLATED AND GOT STUCK IN THE PATIENT'S VESSEL DURING PULLING BACK OF THE DEVICE. THE DISTAL SHAFT TORE OFF. TWO HOURS OF UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE SEPARATED PORTION, WHEN IT WAS DECIDED TO TRANSFER THE PATIENT TO ANOTHER HOSPITAL FOR SURGICAL INTERVENTION. ONCE AT THE OTHER HOSPITAL, THE SEPARATED SHAFT WAS ABLE TO BE RETRIEVED VIA BICEPS FORCEPS AND BALLOON TRAPPING. SURGICAL INTERVENTION WAS NOT REQUIRED. A CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11614595 ↗
• MalfunctionMar 11, 2021Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT SOMETIME DURING THE WEEK OF (B)(6) 2021, THE 3.5 X 20 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED INTO THE ANATOMY AND AIR PREPPED. CONTRAST MIX WAS 40/60. THE DEVICE WAS THEN ADVANCED TO THE HEAVILY CALCIFIED LESION FOR PRE-DILATATION. THE BALLOON WAS INFLATED WITHOUT ISSUE; HOWEVER, AFTER INFLATION, THE BALLOON FAILED TO DEFLATE. NEGATIVE WAS HELD FOR UP TO A COUPLE OF MINUTES, BUT THE BALLOON DID NOT DEFLATE. RESISTANCE WAS FELT DURING REMOVAL SINCE THE BALLOON REMAINED INFLATED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11467216 ↗
• MalfunctionNov 4, 2020Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2020, PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE SAPHENOUS VEIN GRAFT (SVG) TO RIGHT CORONARY ARTERY. DURING ADVANCEMENT OF THE TREK BALLOON DILATATION CATHETER, WITHIN A 6FRENCH GUIDELINER, RESISTANCE WAS MET AND THE TREK BALLOON SEPARATED. THE DEVICE HAD NOT YET EXITED THE GUIDELINER INTO THE ARTERY. THE GUIDELINER CONTAINING THE TREK DEVICE AND SEPARATED BALLOON, WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION AS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10785729 ↗
• MalfunctionSep 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A 3.5X20MM TREK BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED IN AN UNSPECIFIED GUIDING CATHETER WHEN THE SHAFT SEPARATED. THE SEPARATED PORTION WAS REMOVED ALONG WITH THE GUIDING CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE PROCEDURE WAS PERFORMED TO TREAT A NON-CALCIFIED LEFT MAIN OSTIAL, LEFT ANTERIOR DESCENDING, AND CIRCUMFLEX CORONARY ARTERY. A 3.5X20MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER A NON-ABBOTT GUIDE WIRE WITHOUT RESISTANCE. AFTER INFLATION, THE BDC WAS REMOVED WITHOUT RESISTANCE, AND IT WAS NOTED THAT THE SHAFT HAD SEPARATED IN THE UNSPECIFIED GUIDING CATHETER. THE ENTIRE SYSTEM WAS REMOVED, AND NO PORTION OF THE DEVICE REMAINS IN THE ANATOMY. AN UNSPECIFIED 4X8MM XIENCE STENT WAS USED ALONG WITH A NEW GUIDING CATHETER AND GUIDE WIRE TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10567749 ↗
• MalfunctionAug 18, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MID RIGHT CORONARY ARTERY THAT WAS 95% STENOSED. THE 3.5X20MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH A NON-ABBOTT GUIDE EXTENSION. TWO INFLATIONS WERE PERFORMED WITHOUT ISSUE, THE FIRST INFLATION AT 16 ATMOSPHERES (ATM) FOR 14 SECONDS, AND THE SECOND INFLATION AT 12 ATMS FOR 8 SECONDS. THE BALLOON WAS THEN FULLY DEFLATED WITHOUT ISSUE. A SLIGHT RESISTANCE WAS FELT DURING RETRIEVAL OF THE BDC. THE PHYSICIAN WAS NOT SURE WHAT THE BDC HAD RESISTANCE WITH. IT WAS THEN OBSERVED UNDER FLOUROSCOPY THAT THE SHAFT WAS COMING BACK WITHOUT THE BALLOON. THEREFORE, THE GUIDE EXTENSION WAS ADVANCED OVER THE BALLOON TO BE PULL EVERYTHING OUT AS A SINGLE UNIT. THE DETACHED BALLOON WAS NEVER LOOSE IN THE PATIENT AND WAS RETRIEVED THROUGH THE GUIDE EXTENSION. THE PROCEDURE ENDED AT THIS POINT AS THE TARGET LESION WAS TREATED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10422433 ↗
• DeathAug 13, 2020Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE BALLOON WAS INFLATED TO 20 ATMOSPHERES FOR 10 SEC THEN FOLLOWED BY AN INFLATION TO 12 ATMOSPHERES FOR 10 SECONDS USING THE KISSING BALLOON TECHNIQUE. NEGATIVE PRESSURE WAS HELD LESS THAN 1 MINUTE TO DEFLATE THE BALLOONS AS THE PATIENT BECAME UNSTABLE AND ALL THE SYSTEMS WERE PULLED OUT QUICKLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Death; Low Blood Pressure/ Hypotension

  MAUDE report 10405447 ↗
• DeathMay 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING AND LEFT MAIN STEM CORONARY ARTERIES. A 3.50 X 20MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION. THE BDC WAS REMOVED WITH NO SIGNIFICANT RESISTANCE; HOWEVER, IT WAS NOTED THE BALLOON SEPARATED FROM THE SHAFT INSIDE THE GUIDE CATHETER. THE SEPARATED PORTION OF THE BDC WAS SIMPLY REMOVED ALONG WITH THE GUIDE CATHETER AS A SINGLE UNIT. A DELAY IN THE PROCEDURE OCCURRED AND THE PATIENT ULTIMATELY EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death

  MAUDE report 10047905 ↗
• MalfunctionApr 30, 2020Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN UNSPECIFIED LESION. THE 3.5X20MM TREK BALLOON FAILED TO DEFLATE. RESISTANCE WAS NOTED DURING WITHDRAWAL. IT WAS NOT SPECIFIED WHAT THE RESISTANCE WAS WITH. REPORTEDLY, THE DOCTOR HAD TO PULL REALLY HARD AND IT WAS DIFFICULT TO REMOVE. A NEW UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10015205 ↗
• InjuryJan 23, 2020Deflation Problem; Difficult to Remove; Material Rupture; Deflation Problem; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE 3.5X20 MM TREK WAS INFLATED ONE TIME AT NOMINAL PRESSURE IN THE MID RIGHT CORONARY ARTERY (RCA). NEGATIVE PRESSURE WAS HELD FOR THREE SECONDS AND IT MOSTLY DEFLATED. INFLATION DEVICE WAS RETURNED TO NEUTRAL AND A SECOND ATTEMPT TO DEFLATE WAS MADE; NEGATIVE PRESSURE WAS HELD FOR AT LEAST FIVE SECONDS AND IT STILL ONLY PARTIALLY DEFLATED. THE TREK WAS RETRACTED OUT OF THE RCA INTO THE AORTA WITHOUT ISSUE. IT WAS THOUGHT THAT PERHAPS SWITCHING OUT THE INFLATION DEVICE WOULD HELP, SO THE INFLATION DEVICE WAS SWITCHED OUT AND THE TREK WAS INFLATED TO NOMINAL PRESSURE IN THE AORTA. NEGATIVE PRESSURE WAS HELD FOR FIVE SECONDS AND IT DID NOT DEFLATE AT ALL THIS TIME. IT WAS DECIDED TO DELIBERATELY RUPTURE THE TREK BY INFLATING IT PAST THE RATED BURST PRESSURE. THE TREK WAS RUPTURED AND WAS REMOVED FROM THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9622920 ↗
• InjuryJan 9, 2020Deflation Problem; Difficult to Remove; Material Separation; Deflation Problem; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). THE 3.50X38 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS BEING ATTEMPTED TO BE PLACED DISTALLY; HOWEVER, IT COULD NOT CROSS THE MID PART OF THE VESSEL DUE TO CALCIFICATION. THE PHYSICIAN WANTED TO REMOVE THE SDS TO PRE-DILATE THE DISTAL PART OF THE VESSEL SO THE SDS WAS REMOVED. IT WAS NOT NOTED THAT THE STENT HAD DISLODGED UNTIL PRE-DILATATION WAS BEING PERFORMED WITH THE 3.50X20 MM TREK BALLOON DILATATION CATHETER (BDC) IN THE DISTAL VESSEL AND IT WAS SEEN ON ANGIOGRAPHY. NEGATIVE PRESSURE WAS HELD FOR 2 SECONDS; HOWEVER, THE BDC WOULD NOT COMPLETELY DEFLATE AND BECAME STUCK IN THE SAME AREA AS THE STENT IN THE CALCIFICATION. ADDITIONALLY, THE BALLOON SEPARATED FROM THE CATHETER. MULTIPLE WIRE ATTEMPTS WERE PERFORMED TO TRY TO REMOVE THE STENT AND BALLOON BUT WERE UNSUCCESSFUL. BOTH THE STENT AND BALLOON REMAIN STUCK IN CALCIFICATION IN THE VESSEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9572176 ↗