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

Model Number	24700
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified left brachial vein.A 4.0mm x 20mm x 40cm sterling (4f) balloon catheter was advanced for dilation.During the procedure, the catheter became stuck with the non-boston scientific guidewire, leading to cancellation of the procedure.Both the catheter and the guidewire were removed as a single unit.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed buckling 1-3cm from the tip.The reported complaint of frozen on the wire was confirmed.Likely caused by the pulling on the guidewire as the balloon was inflated causing the guidewire to be stuck.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the procedure was cancelled.The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified left brachial vein.A 4.0mm x 20mm x 40cm sterling (4f) balloon catheter was advanced for dilation.During the procedure, the catheter became stuck with the non-boston scientific guidewire, leading to cancellation of the procedure.Both the catheter and the guidewire were removed as a single unit.No patient complications were 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: 19321723
• Report Number: 2124215-2024-27415
• Device Sequence Number: 6358241
• Product Code: DQY
• UDI-Device Identifier: 08714729123538
• UDI-Public: 08714729123538
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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 Expiration Date: 07/19/2026
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0032059262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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