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

Model Number	24700
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were deflation issues, and the procedure was rescheduled.A fg sterling otw, 5.0mmx100mmx135cm (4f) was selected for the index procedure.After inflation, however, the balloon wasn't able to be deflated.The balloon had to be pulled back together with the sheath out of the patient.Because the position of the sheath was lost, the procedure was discontinued and scheduled to be completed in the future.The patient status is stable and doing well.
Event or Problem Description
It was reported that there were deflation issues, and the procedure was rescheduled.A fg sterling otw, 5.0mmx100mmx135cm (4f) was selected for the index procedure.After inflation, however, the balloon wasn't able to be deflated.The balloon had to be pulled back together with the sheath out of the patient.Because the position of the sheath was lost, the procedure was discontinued and scheduled to be completed in the future.The patient status is stable and doing well.
Additional Manufacturer Narrative
Device evaluation by manufacturer: returned product consisted of a sterling balloon catheter with an unknown 0.018 inch guidewire, unknown inflation device, and an unknown 6f sheath.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple stretching to the inflation lumen.There is a kink to the inflation lumen 36cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that could have contributed to the reported event.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16708934
• Report Number: 2124215-2023-16426
• Device Sequence Number: 12244903
• Product Code: DQY
• UDI-Device Identifier: 08714729122814
• UDI-Public: 08714729122814
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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: 10/18/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0030376780
• 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: 04/03/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown