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	07/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The >50% stenosed target lesion was located in a fistula.A 7.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during initial inflation at 20 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The >50% stenosed target lesion was located in a fistula.A 7.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during initial inflation at 20 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a gladiator elite 7.0 x40, 40cm was returned for analysis.A longitudinal tear was identified in the balloon material.The tear measured 24 mm in length and extended from a position 10mm proximal of the proximal markerband to 14 mm distal of the proximal markerband.A visual and microscopic examination of the balloon material identified no further issues.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified a kink 10mm distal of the proximal markerband.A visual and tactile examination identified no damage to the tip.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: 10365087
• Report Number: 2134265-2020-10483
• Device Sequence Number: 3043938
• Product Code: LIT
• UDI-Device Identifier: 08714729809784
• UDI-Public: 08714729809784
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2020

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: 07/07/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0024066907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 60