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

Model Number	24690
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 28-apr 2023.It was reported that balloon leak was encountered.The 90% stenosed target lesion was located in the carotid artery.After the left femoral artery was punctured and an 8f non-boston scientific (bsc) guide catheter was placed and a non-bsc guidewire was reached at the distal left common carotid artery, a 9x40 wallstent was then deployed.Post-dilatation was performed with a 6.0mmx30mmx135cm (4f) sterling balloon catheter.However, during third inflation at 7 atmospheres, the balloon leaked.The balloon was removed and replaced, and the procedure was completed.The stenosis was significantly relieved, with good stent attachment, ideal position and smooth blood flow.The patient was stable and had no discomfort reported.However, returned device analysis revealed a balloon pinhole.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 12mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found a pinhole in the balloon which would cause a leak.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16899973
• Report Number: 2124215-2023-22829
• Device Sequence Number: 12457932
• Product Code: DQY
• UDI-Device Identifier: 08714729757276
• UDI-Public: 08714729757276
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2023

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: 12/15/2024
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0028573540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 8F GUIDING CATHETER.; GUIDEWIRE: MUDSKIPPER.; INTRODUCER SHEATH: 8F SHEATH.
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 60 KG