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

Model Number	24716
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 in the balloon 90mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found a pinhole in the balloon.
Event or Problem Description
Reportable based on device analysis completed on 07-mar-2023.It was reported that balloon inflation issues occurred.The patient underwent lower limb angioplasty.The 60-80% stenosed target lesion was located in the severely calcified and moderately tortuous superficial femoral artery and/or popliteal region.A 5.0x220x150-hybrid sterling balloon catheter was advanced for dilation but when inflating the balloon, it could not be fully inflated to nominal atmospheres.Physician tried twice and same thing happen.The balloon was withdrawn, and the procedure was completed with another 5mmx 220mm 90cm sterling balloon catheter.No patient complications were reported.However, returned device analysis revealed balloon pinhole.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16631917
• Report Number: 2124215-2023-11325
• Device Sequence Number: 5334922
• Product Code: LIT
• UDI-Device Identifier: 08714729845409
• UDI-Public: 08714729845409
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2023

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: 03/07/2025
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0029002479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• 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
• Patient Race: Asian