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

Model Number	24700
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that deflation failure occurred.A 7.0mmx40mmx80cm (4f) sterling balloon catheter was advanced for dilation.However, during the procedure, the balloon could not be deflated.The sheath was replaced with 7fr, and the balloon was removed.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).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 that the shaft is separated 42.2cm from the hub.The distal section of the device is missing and did not return for analysis.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.
Event or Problem Description
It was reported that deflation failure occurred.A 7.0mmx40mmx80cm (4f) sterling balloon catheter was advanced for dilation.However, during the procedure, the balloon could not be deflated.The sheath was replaced with 7fr, and the balloon was removed.There were no patient complications nor injuries reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12457951
• Report Number: 2134265-2021-11425
• Device Sequence Number: 11946731
• Product Code: DQY
• UDI-Device Identifier: 08714729124108
• UDI-Public: 08714729124108
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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 Expiration Date: 03/10/2024
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0026952034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/12/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention