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

Model Number	24700
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon failed to deflate.A 6.0mm x 40mm x 80cm sterling balloon was selected for use in a fistuloplasty procedure.The balloon was inflated at 10 atmospheres (atm) for 90 seconds.Several minutes were spent attempting to deflate the balloon.The balloon would not deflate on aspiration.The balloon was punctured twice percutaneously to assist deflation.The balloon was partially deflated and removed via the access sheath.The balloon was examined upon removal from patient.There was no obvious damage, but it was tested on the table, and it still would not deflate fully.The procedure was successfully completed with a 6.0mm x 40mm x 80cm sterling balloon.There were no patient complications reported.The patient did well.
Event or Problem Description
It was reported that the balloon failed to deflate.A 6.0mm x 40mm x 80cm sterling balloon was selected for use in a fistuloplasty procedure.The balloon was inflated at 10 atmospheres (atm) for 90 seconds.Several minutes were spent attempting to deflate the balloon.The balloon would not deflate on aspiration.The balloon was punctured twice percutaneously to assist deflation.The balloon was partially deflated and removed via the access sheath.The balloon was examined upon removal from patient.There was no obvious damage, but it was tested on the table, and it still would not deflate fully.The procedure was successfully completed with a 6.0mm x 40mm x 80cm sterling balloon.There were no patient complications reported.The patient did well.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed that the shaft was stretched in multiple locations.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; 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: 20620496
• Report Number: 2124215-2024-69372
• Device Sequence Number: 8820307
• Product Code: DQY
• UDI-Device Identifier: 08714729123798
• UDI-Public: 08714729123798
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0034026224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown