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

Model Number H74939032300410

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2020

Event Type  malfunction  

Event Description

Balloon burst prior to reaching nominal pressure, device barely started to inflate before bursting.Balloon was flushed per manufacture guideline.Surgeon hooked up inflation device once balloon was in the correct location and began to inflate balloon, prior to reaching nominal inflation pressure of 6, the balloon burst.Product removed, a new product, same manufacturer, was used and worked properly.

• Brand Name: STERLING
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10367040
• MDR Text Key: 201693170
• Report Number: 10367040
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729860136
• UDI-Public: (01)08714729860136(17)201018(10)23673349
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H74939032300410
• Device Catalogue Number: H74939032300410
• Device Lot Number: 23673349
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1