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	04/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located above the anstomotic stoma.A 4.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The physician removed the balloon immediately.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located above the anstomotic stoma.A 4.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The physician removed the balloon immediately.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: gladiator device - 4x40x75cm was received for analysis.A visual examination identified that the balloon material had a complete circumferential tear located approximately 40mm distal of the proximal balloon bond.The distal section of balloon material noted was pushed distally towards the tip.A visual and tactile examination identified that the shaft was of the device was severely stretched and kinked at more than one location between the distal and proximal balloon bonds.This type of damage is consistent with excessive force being applied to the device.A visual and microscopic examination identified that the distal markerband was damaged and loose on the shaft due to the stretching.A visual microscopic examination identified no damage or issues with the tip 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: 10132743
• Report Number: 2134265-2020-07734
• Device Sequence Number: 3791755
• Product Code: LIT
• UDI-Device Identifier: 08714729809609
• UDI-Public: 08714729809609
• 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): 08/20/2020

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: 04/24/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0023692059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 60