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

Model Number	24700
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter title: (b)(6).
Event or Problem Description
It was reported that a balloon issue occurred.A 3.0mm x 40mm x 90cm sterling over-the-wire balloon catheter was selected for a percutaneous transluminal angioplasty procedure in the superficial femoral artery.During the procedure, the balloon was separated from the shaft.The balloon was removed.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Initial reporter title: buyer device eval by manufacturer: the returned device consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.Inspection of the remainder of the device showed no other damage or irregularities.Product analysis could not confirm the reported separation.
Event or Problem Description
It was reported that a balloon issue occurred.A 3.0mm x 40mm x 90cm sterling over-the-wire balloon catheter was selected for a percutaneous transluminal angioplasty procedure in the superficial femoral artery.During the procedure, the balloon was separated from the shaft.The balloon was removed.The procedure was completed with another of the same device.There were no patient complications reported.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14190607
• Report Number: 2134265-2022-04583
• Device Sequence Number: 4378331
• Product Code: LIT
• UDI-Device Identifier: 08714729860143
• UDI-Public: 08714729860143
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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: 01/20/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0028720986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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