MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL MONORAIL PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939147351210

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

While attempting to use a sterling sl monorail 4f pta balloon dilatation catheter, the product defaulted and the balloon would not release.The product broke into 2 pieces.Fda safety report id# (b)(4).

• Brand Name: STERLING SL MONORAIL PTA BALLOON DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 13417474
• MDR Text Key: 284967710
• Report Number: MW5107106
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729782728
• UDI-Public: (01)08714729782728
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: H74939147351210
• Device Catalogue Number: H4939147351210
• Device Lot Number: 25550899
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1