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 Consequences Or Impact To Patient (2199)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 5.0 x40, 40cm gladiator balloon catheter was advanced for dilation.However, during inflation at 12 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.
Event or Problem Description
It was reported that balloon rupture occurred.A 5.0 x40, 40cm gladiator balloon catheter was advanced for dilation.However, during inflation at 12 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.:gladiator elite 5.0 x40, 40cm was returned for analysis.A visual examination identified that the balloon wings had been subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied; the balloon was inflated to its rate of burst pressure and pressure held for 30 seconds without issue.A vacuum was then applied.The inflation device was verified at 24 atmospheres, before and after use.This inflation to rate of burst pressure of 24 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination of the shaft of the device found no issues.A visual examination found no issues or damage to the markerbands of the device.No other issues were identified during the product analysis.

• 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: 10475024
• Report Number: 2134265-2020-12021
• Device Sequence Number: 2809275
• Product Code: LIT
• UDI-Device Identifier: 08714729809661
• UDI-Public: 08714729809661
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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: 11/03/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0024710764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1