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

Model Number	24686
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a left arteriovenous fistula.A 7.0 x 40, 75 cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The device was replaced with another 8.0 x 40, 75 cm gladiator elite balloon catheter; however, during inflation at 18 atmospheres, the balloon ruptured and the balloon parts came off.The broken fragments were completely removed from the patient's body with a snare.The procedure was completed with a non-bsc device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon material had a complete circumferential tear located approximately 20mm distal of the proximal markerband.Approximately 35mm of balloon material remained attached to the shaft of the device.The distal section of balloon material was not returned for analysis.A visual and tactile examination identified that the shaft was completely broken at approximately 72mm distal of the proximal markerband.The detached section of shaft, the distal markerband, the tip and distal section of balloon material were not returned for analysis.The shaft was also noted to be kinked and stretched distal of the balloon circumferential tear.This type of damage is consistent with excessive tensile force being applied to the device.A visual microscopic examination identified that only the proximal markerband remained intact on the device.The distal markerband was not returned for analysis.A visual microscopic examination identified that the tip was completely detached from the device.The tip was not returned for analysis.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a left arteriovenous fistula.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The device was replaced with another 8.0 x40, 75cm gladiator elite balloon catheter; however, during inflation at 18 atmospheres, the balloon ruptured and the balloon parts came off.The broken fragments were completely removed from the patient's body with a snare.The procedure was completed with a non-bsc device.No patient complications were reported and the patient's status was fine.It was further reported that there was a 90% stenosis, with non-calcified and non-tortuous target lesion.

• 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: 9152998
• Report Number: 2134265-2019-11980
• Device Sequence Number: 2694028
• Product Code: LIT
• UDI-Device Identifier: 08714729809876
• UDI-Public: 08714729809876
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2020
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0020256595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention