GLIDESHEATH SLENDER 80-1050Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00389701012049), received between Jan 25, 2019 and Jan 22, 2025 — classified as 6 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (14 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE USER FACILITY REPORTED THAT A TERUMO 5FR GLIDESHEATH SLENDER INTRODUCER WAS USED IN A RADIAL ARTERY. WHILE RETRACTING A 7X4 PASSEO XEO (MINIMUM 5FR) BALLOON THROUGH THE SHEATH, THE BALLOON WAS FULLY ASPIRATED. THE SHEATH BEGAN TO COME OUT FROM THE BACK END AND EVENTUALLY BECAME COMPLETELY DISLODGED. A SKINNY NEEDLE DRIVER WAS USED TO RETRACT THE ENTIRE SHEATH THROUGH THE BACK END. THERE WAS NO BLOOD LOSS OR INJURY DUE TO THE EVENT, WHICH OCCURRED INTRA-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210890 ↗
• InjuryMar 29, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT DURING A FISTULA GRAM VIA RADIAL ARTERY ACCESS PHYSICIAN INTRODUCED AN 8MMX60MM BARD ULTRAVERSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON THROUGH A 4/5 TERUMO GLIDESHEATH SLENDER SHEATH TO TREAT LESION. UPON TRYING TO REMOVE BALLOON THE BALLOON BECAME STUCK IN SHEATH AND WHEN THE PHYSICIAN PULLED HARDER TO GET IT OUT, THE HUB OF THE SHEATH BROKE OFF.THE REMAINING SHEATH WITH THE BALLOON STUCK WITHIN IT, IT WAS REMOVED. THERE WAS NO PATIENT HARM, AND THE CASE WAS COMPLETED AS PLANNED AFTER PRESSURE HELD ON ACCESS SITE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 03 MAR 2023: AS THE PHYSICIAN WAS ATTEMPTING TO REMOVE BALLOON THROUGH THE SHEATH, THE SHEATH BROKE WITHIN THE HUB, WHICH WAS OUTSIDE THE PATIENT AND REMAINED ON BALLOON CATHETER AND WIRE. REMAINDER OF SHEATH WAS ALREADY PARTIALLY EXPOSED AND WAS REMOVED AT THE SAME TIME AS THE BALLOON AND WIRE. THE PORTION THAT BROKE WAS OUTSIDE OF THE PATIENT. THE PATIENT WAS STABLE. THERE WAS NO STENOSIS OR CALCIFICATION PRESENT IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637075 ↗
• MalfunctionSep 19, 2022Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  THE USER FACILITY REPORTED THAT THE WIRE SEEMED TO HAVE A PROMINENT WELD THAT PREVENTED THE WIRE FROM PASSING THROUGH THE NEEDLE. THERE WAS NO PATIENT INJURY, OR BLOOD LOSS. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446471 ↗
• MalfunctionSep 19, 2022Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  THE USER FACILITY REPORTED THAT THE WIRE SEEMED TO HAVE A PROMINENT WELD THAT PREVENTED THE WIRE FROM PASSING THROUGH THE NEEDLE. THERE WAS NO PATIENT INJURY, OR BLOOD LOSS. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446374 ↗
• MalfunctionSep 19, 2022Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  THE USER FACILITY REPORTED THAT THE WIRE SEEMED TO HAVE A PROMINENT WELD THAT PREVENTED THE WIRE FROM PASSING THROUGH THE NEEDLE. THERE WAS NO PATIENT INJURY, OR BLOOD LOSS. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446372 ↗
• MalfunctionJun 22, 2021Material Deformation; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED ON 01JULY2021: THE TYPE OF PROCEDURE WAS A MAA. THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042779 ↗
• InjuryMay 28, 2021Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT (B)(4). THE EVENT DESCRIPTION STATES: "PATIENT IN GATH LAB FOR LEFT INTERNAL CAROTID ARTERY STENT. RIGHT ULNAR ARTERY SHEATH PLACED. DURING SHEATH EXCHANGE, THE SHEATH BROKE OFF IN THE ULNAR ARTERY. VASCULAR SURGERY CALLED." "ULNAR ARTERY CUTDOWN PERFORMED AND REMAINING SHEATH PIECE REMOVED." ADDITIONAL INFORMATION WAS RECEIVED ON 11MAY2021. THE PATIENT'S CONDITION WAS STABLE. THERE WAS NO TORTUOUS ANATOMY NOTED DURING THE ACCESS. THERE WAS 100ML OF BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11900345 ↗
• InjuryMay 18, 2021Material Separation; Material Separation

  A MAUDE DATABASE SEARCH CONDUCTED ON 20APR2021 FOUND A MAUDE REPORT NUMBER MW5099825. THE EVENT DESCRIPTION STATES: "PATIENT PRESENTED FOR RIGHT RADIAL ARTERY ACCESS UNDER ULTRASOUND GUIDANCE IN CATH LAB DURING HOSPITALIZATION. AFTER THE PROCEDURE, IT WAS DISCOVERED THAT PATIENT HAD RETAINED A PIECE OF THE TERUMO FRENCH # 4 SHEATH. UPON ASSESSMENT AND ATTEMPTS TO RETRIEVE, IT WAS DETERMINED THAT THE SHEATH WOULD REMAIN, AS THERE WAS NO HARM TO PATIENT'S VESSEL AND GOOD FLOW TO THE ARM. NO FURTHER ISSUES NOTED, AND PATIENT DISCHARGED IN GOOD CONDITION. FDA SAFETY REPORT ID # (B)(4)."

  Patient problems: Foreign Body In Patient

  MAUDE report 11846485 ↗
• MalfunctionMar 9, 2021Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED 25MAR2021. ACCESS WAS CHALLENGING IN THIS CASE. THE RADIAL ARTERY WAS ON THE SMALL SIDE, APPROXIMATELY 1.92MM. THE PATIENT HAD A LOT OF OTHER HEALTH ISSUES OCCURRING FOLLOWING A MISCARRIAGE. A D&C WAS PERFORMED WHICH RESULTED IN THE HEMORRHAGE. MULTIPLE ACCESS ATTEMPTS WERE MADE WHICH COULD HAVE SENT THE ARTERY INTO SPASM. THE TIP OF THE SHEATH APPEARED TO BE HUNG UP OUTSIDE THE SKIN AND WAS NOT ADVANCED INTO THE ARTERY. THE PATIENT'S FINGERS WERE TAPED TO THE ARM-BOARD TO ASSIST WITH HYPEREXTENSION OF THE WRIST TO RAISE THE RADIAL ARTERY. INITIAL FREEZING WAS 1ML. ADDITIONAL LOCAL FREEZING WAS GIVEN WHEN PHYSICIAN MOVED ACCESS LOCATION MORE PROXIMAL TO WRIST.

  Patient problems: Pain

  MAUDE report 11446001 ↗
• MalfunctionMar 9, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 12, 2021. THE FRENCH SIZE OF THE BALLOON WAS A 6F.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445146 ↗
• MalfunctionFeb 16, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS PERFORMING BALLOON-ASSISTED MATURATION PROCEDURE FOR A DIALYSIS FISTULA. HE GAINED ACCESS VIA THE RADIAL ARTERY WITH A 5FR GLIDESHEATH SLENDER. THE DOCTOR FIRST USED A 6X80 CORDIS POWERFLEX PTA BALLOON, AND THEN COMPLETED THE PROCEDURE WITH A 7X80 CORDIS POWERFLEX BALLOON. AS HE WAS REMOVING THE BALLOON, THE TOP PORTION OF THE SHEATH THAT INCLUDES THE VALVE WAS DETACHED FROM THE BODY OF THE SHEATH. THE DOCTOR WAS FORCED TO REMOVE THE BALLOON AND THE REST OF THE SHEATH TOGETHER WITH THE BALLOON CATHETER STILL IN THE SHEATH BODY. HE IMMEDIATELY APPLIED DIRECT PRESSURE TO THE ACCESS SITE AND WAS ABLE TO SUCCESSFULLY PLACE A TR BAND. THERE WAS NO UNEXPECTED BLOOD LOSS, HOWEVER THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 22JAN2021. THE PART NUMBER FOR THE CORDIS POWERFLEX PRO USED WAS 4400708S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334241 ↗
• MalfunctionDec 18, 2020Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON 15JAN2021. THE BALLOONS USED ON A 0.035" PLATFORM. OTHER INTERVENTIONS THAT WERE PERFORMED ON THE LESION WAS A CSI ATHERECTOMY. THE VESSEL THAT WAS BEING TREATED WAS THE (AT) ACCESS VESSEL. THE BALLOON WAS ALLOWED TO DEFLATE COMPLETELY BEFORE ATTEMPTING TO PULL THE BALLOON BACK THROUGH THE SHEATH AS IT WAS VERIFIED UNDER FLOURO. THE BALLOON CATHETER SHAFTS WERE NOT KINKED OR BENT PRIOR TO REMOVING. THE BALLOON WAS ALLOWED TO DEFLATE 30-45 SECONDS BEFORE REMOVING. THE SHEATH SHAFT DID SEPARATE COMPLETELY FROM THE HUB AND GET PULLED BACK THROUGH THE VALVE, WHEN REMOVING THE BALLOON. THE SUPERFICIAL FEMORAL ARTERY (SFA/POP) WAS HEAVILY CALCIFIED OR DISEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11037419 ↗
• InjuryNov 15, 2020Break; Break

  THE USER FACILITY REPORTED THAT WHEN REMOVING THE LUTONIX 7 BY 40 ECB BALLOON OUT OF THE GLIDESHEATH SLENDER SHEATH, THE SHEATH SEPARATED FROM THE SHEATH HUB. THE DOCTOR HAD TO PERFORM A CUT DOWN OF THE TIBIAL TO GET THE PIECE. THE PROCEDURE WAS EXTENDED APPROXIMATELY THREE HOURS. ADDITIONAL INFORMATION WAS RECEIVED 11NOV2020. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS COMPLETED AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10841629 ↗
• InjuryNov 9, 2020Break; Break

  THE USER FACILITY REPORTED THAT THE GLIDESHEATH SLENDER SHEATH WAS USED IN THE ANTERIOR TIBIAL ARTERY TO GAIN RETROGRADE ACCESS. AT SOME POINT THE HUB BECAME DETACHED FROM THE SHEATH, AND THE ENTIRE TUBE PORTION OF THE SHEATH WAS INSIDE THE ARTERY. THEY HAD PUT A LUTONIX 7MMX40MM AND A MUSTANG 6MMX40MM (BOTH MARKED 5 FR) THROUGH THE SHEATH TO TREAT. THEY ENDED UP HAVING TO CUT DOWN ON THE PATIENT'S AT AND REMOVE THE SHEATH THAT WAY. SURGICAL REMOVAL OF THE SHEATH WAS REQUIRED. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 02NOVEMBER2020: TESTING WAS PERFORMED TO CONFIRM THAT ALL PIECES WERE REMOVED FROM THE PATIENT. THERE WAS NO SIGNIFICANT BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 05NOVEMBER2020: TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: THAT THE ORIGINAL INTENDED PROCEDURE WAS A SUPERFICIAL FEMORAL ARTERY (SFA) ARTERIOGRAM VIA LEFT TIBIAL APPROACH. WHEN REMOVING THE LUTONIX 7X40 DRUG COATED BALLOON OUT OF THE SHEATH, THE SHEATH SEPARATED FROM THE SHEATH HUB. DOCTOR HAD TO PERFORM A CUT DOWN OF THE TIBIAL TO GET THE PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10810682 ↗
• MalfunctionOct 29, 2020Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2020: THE BALLOON USED WAS AN OTW. THE FR SIZE WAS UNKNOWN HOWEVER IT DID FIT IN THE SHEATH AND CAN BE LOOKED UP. IT WAS THE (SFA) SUPERFICIAL FEMORAL ARTERY)/POP VESSEL. IT WAS UNKNOWN IF A HEMOSTATIC ADAPTOR WAS ATTACHED TO THE ABBOTT CATHETER SHAFT, BUT THE PHYSICIAN/TECH PULLED NEGATIVE ON THE BALLOON AND THEN RELEASED PRESSURE TO PREVENT PANCAKING. THE BALLOON COULD DEFLATE COMPLETELY BEFORE ATTEMPTING TO PULL THE BALLOON BACK THROUGH THE SHEATH. THE SHEATH SHAFT SEPARATED COMPLETELY FROM THE HUB AND WAS PULLED BACK THROUGH THE VALVE, WHEN REMOVING THE ABBOTT BALLOON. RESISTANCE WAS FELT WHILE WITHDRAWING THE BALLOON THROUGH THE SHEATH AND BROKE THE SHEATH. THIS WAS THE FIRST AND ONLY DEVICE USED WITH THIS SHEATH. THERE WAS NO DAMAGE NOTED ON THE SHEATH PRIOR TO INSERTION. THERE WAS NO DIFFICULTY INSERTING THE SHEATH, IT WENT IN FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10755460 ↗
• MalfunctionOct 22, 2020Fracture; Fracture

  THE USER FACILITY REPORTED THAT THERE WAS DECONSTRUCTION OF SHEATH UPON REMOVAL OF LUTONIX BALLOON FROM DORSALIS PEDIS (DP) ACCESS. THE DOCTOR HAD DP ACCESS OF THE FOOT WITH A 5FR GLIDESHEATH SLENDER SHEATH. THE PHYSICIAN WAS INTERVENING THE SUPERFICIAL FEMORAL ARTERY (SFA) USING BALLOONS, AND CSI DEVICES FROM HIS ACCESS IN THE FOOT. ALL DEVICES USED WERE 5FR DEVICES, AND UPON REMOVAL OF A 5X150 LUTONIX BALLOON, THE ENTIRE INNER SHEATH CAME OUT OF PATIENT. LEAVING JUST THE HUB OF THE SHEATH SECURED WITH A TEGADERM TO THE PATIENT. THE DOCTOR HAD WIRE ACCESS AND PLACED A 2ND SLENDER SHEATH WITHOUT ISSUE AND COMPLETED THE CASE. NO REPORTED CONSEQUENCE TO THE PATIENT. THE PATIENT WAS IN STABLE CONDITION. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 30SEPT2020. THE CSI DEVICE WAS A DIAMOND BACK 360 1.5 SOLID CROWN. LUTONIX BALLOON 5 X 150 THAT WAS USED WAS A .035". THE INTERVENTIONS THAT WERE PERFORMED ON THE SUPERFICIAL FEMORAL ARTERY (SFA) LESION WERE 1 ATHERECTOMY, 2 DRUG COATED BALLOONS (DCB), AND 1 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). A HEMOSTATIC ADAPTOR WAS NOT ATTACHED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10719295 ↗
• MalfunctionOct 9, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THEY HAD A 5FR RADIAL GLIDESHEATH SLENDER, HAD COME APART UPON REMOVAL. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. ADDITIONAL INFORMATION WAS RECEIVED ON 17SEPTEMBER2020: LATERAL PATELLOFEMORAL ANGLE (LPA) WAS IN THE PATIENT, SO IT WAS IN THE RIGHT INTERNAL JUGULAR VEIN. NO FURTHER INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10657135 ↗
• MalfunctionOct 9, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THEY HAD A 5FR RADIAL SHEATH, COME APART UPON REMOVAL AT THE END OF THE CASE. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 17SEPTEMBER2020: BALLOON ANGIOPLASTY WITH CHARGER BALLOONS- ARCH IN THE FIRST PATIENT, SO THE SHEATH WAS IN THE FEMORAL ARTERY. NO FURTHER INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10657105 ↗
• MalfunctionSep 14, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED A KINK AT THE HUB OF THE INVOLVED GLIDESHEATH SLENDER. IT WAS AN UAE PATIENT. THE SHEATH WAS COMPLETELY KINKED, THE HUB WAS 180 DEGREES FACING THE WRONG WAY. IT STRAIGHTENS OUT ONCE YOU HOLD IT DOWN, AND THEN PLACE A CATHETER IN. THE PATIENT'S CONDITION WAS STABLE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE WAS COMPLETED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10528431 ↗
• MalfunctionMar 13, 2020Break; Break

  THE USER FACILITY REPORTED THAT THE BALLOON WENT IN AND UP, HOWEVER WHILE TAKING THE BALLOON OUT THROUGH THE GLIDESHEATH SLENDER THEY HAD TROUBLE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 18FEB2020. THE SHEATH SHAFT WAS BROKEN AND SEPARATED OFF THE HOUSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9829149 ↗
• MalfunctionFeb 26, 2020Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE GLIDESHEATH SLENDER WIRE WOULD NOT ADVANCE INTO THE BARREL OF THE NEEDLE. POST PROCEDURE THEY ATTEMPTED TO ADVANCE THE BACK OF THE WIRE THROUGH THE NEEDLE, AND THE WIRE SUCCESSFULLY ADVANCED THROUGH THE ENTIRE LENGTH OF THE NEEDLE. THEY OPENED A SECOND KIT AND USED THAT WIRE WHICH ADVANCED THROUGH THE NEEDLE WITH NO RESISTANCE. THE PATIENT WAS UNAFFECTED BY THIS ISSUE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 29JAN2020. THE PROCEDURE WAS A DIAGNOSTIC HEART CATHETERIZATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9758455 ↗
• MalfunctionDec 20, 2019Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE GLIDESHEATH SLENDER WIRE WOULD NOT PASS THROUGH THE NEEDLE. THE NEEDLE WAS FLUSHED; HOWEVER, NOT STERILIZED. THE PATIENT'S CONDITION WAS GOOD, AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. AN ADDITIONAL 80-1050 WAS USED. ADDITIONAL INFORMATION WAS RECEIVED ON 03 DEC 2019. THE PROCEDURE WAS A DIAGNOSTIC LEFT HEART CATHETERIZATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9502719 ↗
• MalfunctionNov 22, 2019Obstruction of Flow; Obstruction of Flow

  THE USER FACILITY REPORTED THAT THE DOCTOR INVOLVED GLIDESHEATH SLENDER WAS USED. THE DOCTOR COMPLAINED OF BEING ABLE TO WITHDRAW BLOOD FROM THE THREE-WAY STOCK COCK OF A SHEATH THAT WAS IN THE RADIAL ARTERY, HOWEVER IT WOULD NOT FLUSH FORWARD. HE PLACED A WIRE IN THE SHEATH AND EXCHANGED IT OUT FOR A NEW SHEATH WITHOUT FURTHER ISSUE. THE BLAND LIVER EMBO PROCEDURE WAS A SUCCESS. THE PATIENT WAS IN STABLE CONDITION. THE EVENT OCCURRED PRE-TREATMENT. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 31OCT2019. IT IS UNKNOWN WHERE THE BLOCKAGE OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9363176 ↗
• MalfunctionOct 31, 2019Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE GLIDESHEATH SLENDER SHEATH KINKED. IT FOLDED OVER ON ITSELF AT THE HUB; THEY HAD TO HOLD IT TO KEEP IT FROM FOLDING OVER. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT WAS IN SATISFACTORY CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 08OCT2019. THE TYPE OF PROCEDURE WAS A RADIAL ARTERY VISCERAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9261193 ↗
• InjuryOct 1, 2019Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT WHILE THE DOCTOR WAS PERFORMING A LEFT HEART CATHETERIZATION WITH A TIGER CATHETER, THEY CANNULATED THE RIGHT CORONARY ARTERY AND THE TIP OF THE TIGER SLIPPED INTO CONUS AND THE PATIENT WENT INTO V-FIB. THE PATIENT WAS SHOCKED AND WAS MOVING QUITE A BIT WITH THE TIGER CATHETER EXITING THE 5FR GLIDESHEATH SLENDER. WHEN THE DOCTOR TRIED TO PULL THE TIGER OUT, HE NOTICED THAT THE SHEATH WAS ACCORDION. AS SOON AS THE TIGER WAS PULLED OUT, THE SHEATH STARTED LEAKING FROM BETWEEN THE HUB AND WHERE THE SHEATH IS WELDED TO IT. THE DOCTOR CUT THE SHEATH, REWIRED DISTAL PART OF THE SHEATH AND REPLACED TO FINISH THE CASE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 11SEPT19. THERE WAS NO BLOOD LOSS. THE PHYSICIAN USED A CORDIS FEMORAL SHEATH BECAUSE HE NEEDED .035. AND THEN REPLACED WITH 6FR GLIDESHEATH SLENDER. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 9141310 ↗