MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24716
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 2.5x220x150 (4f) sterling balloon catheter was advanced for dilatation, however; it was noted that the contrast was dripping at the end of the balloon when it was inflated as the balloon ruptured.The device was completely removed and no patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 2.5x220x150 (4f) sterling balloon catheter was advanced for dilatation, however; it was noted that the contrast was dripping at the end of the balloon when it was inflated as the balloon ruptured.The device was completely removed and no patient complications were reported.It was further reported that the procedure was completed with another of same device and the patient's status was good.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11520775
• Report Number: 2134265-2021-03585
• Device Sequence Number: 4049551
• Product Code: LIT
• UDI-Device Identifier: 08714729860075
• UDI-Public: 08714729860075
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

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: 02/10/2022
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0025860715
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1