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

Model Number	H74939147351210
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 13417474
• Report Number: MW5107106
• Device Sequence Number: 17300182
• Product Code: LIT
• UDI-Device Identifier: 08714729782728
• UDI-Public: (01)08714729782728
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown