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

Model Number 24686

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2019

Event Type  malfunction  

Event Description

It was reported that balloon pinhole occurred.The target lesion was located in an arteriovenous fistula.A 12.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, the balloon would not inflate due to a small hole.The procedure was completed with a different device.No patient complications were reported and the patient was fine.

Event Description

It was reported that balloon pinhole occurred.The target lesion was located in an arteriovenous fistula.A 12.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, the balloon would not inflate due to a small hole.The procedure was completed with a different device.No patient complications were reported and the patient was fine.

Manufacturer Narrative

Device evaluated by mfr.: the complaint device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.No tears or holes were visible in the balloon.The device was attached to an encore inflation device and positive pressure was applied, however the balloon did not inflate.The device was soaked in the waterbath at 37 degrees celsius to soften hardened medium or blood that may have been present in the device.The device was removed from the bath and was attached to an encore inflation device and positive pressure was applied.A pinhole leak was identified 11mm proximal from the proximal end of the markerband.No other issues were noted.A visual and microscopic examination of the balloon material identified no issues that could have contributed to the complaint incident.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 no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

• Brand Name: GLADIATOR ELITE
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9521618
• MDR Text Key: 177134545
• Report Number: 2134265-2019-16073
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729809555
• UDI-Public: 08714729809555
• Combination Product (y/n): N
• PMA/PMN Number: K132810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0024485244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1