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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in an internal arteriovenous fistula.A 5.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a gladiator 5 x 40,24atm, 40cm was returned for analysis.A visual examination identified that the balloon was 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 as per gladiator specification for 30 seconds.A vacuum was then applied, and the device deflated within 10 seconds - this is within the deflation time as per gladiator specification.No issues were noted on deflation.The inflation device was verified before and after use.This inflation to rate of burst pressure 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 of the marker bands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no issues with the shaft.A visual and tactile examination identified no issues with tip of this device.No issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in an internal arteriovenous fistula.A 5.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient's 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: 10999281
• Report Number: 2134265-2020-17594
• Device Sequence Number: 3477877
• 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): 02/08/2021

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: 04/27/2023
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0025474989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 12/13/2020
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 43