MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24686
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The severely stenosed target lesion was located in an arteriovenous internal fistula in the severely tortuous and severely calcified vessel.A 5.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during first inflation, the balloon ruptured.The device was removed and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a gladiator elite 5.0 x40, 40cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately at the centre of the balloon material.The proximal section of balloon material was also torn longitudinally beginning at the circumferential tear and extending for approximately 15mm proximally.The distal section of balloon material was also torn longitudinally beginning at the circumferential tear and extending for approximately 19mm distally.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed damage to tip of the device.This type of damage is consistent with the device encountering resistance and excessive force being applied to the device.A visual and tactile examination found the shaft of the device to be stretched/damaged between both markerbands.This type of damage is consistent with excessive tensile force being applied to the device.The shaft was also found to be severely kinked at approximately 90mm distal of the strain relief.No other issues were noted with shaft.Both markerbands were undamaged and present on the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The severely stenosed target lesion was located in an arteriovenous internal fistula in the severely tortuous and severely calcified vessel.A 5.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during first inflation, the balloon ruptured.The device was removed and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

• Brand Name: GLADIATOR ELITE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11962487
• Report Number: 2134265-2021-07384
• Device Sequence Number: 19744841
• Product Code: LIT
• UDI-Device Identifier: 08714729809661
• UDI-Public: 08714729809661
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2023
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0026252974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 60