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

Model Number	24716
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 5.0x220x150-hybrid sterling balloon was used.During the course of the procedure, the balloon ruptured.No patient complication reported.
Additional Manufacturer Narrative
B3.Date of event-the event date of 01jan2024 is an estimated based of the aware date of 23jan2024 as the exact date was not reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 5.0x220x150-hybrid sterling balloon was used.During the course of the procedure, the balloon ruptured.No patient complication reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole in the balloon 50mm from the tip.B3.Date of event-the event date of 01jan2024 is an estimated based of the aware date of 23jan2024 as the exact date was not reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18650984
• Report Number: 2124215-2024-04457
• Device Sequence Number: 15231804
• Product Code: LIT
• UDI-Device Identifier: 08714729845409
• UDI-Public: 08714729845409
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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 Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0032686282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown