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	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation issue occurred.The target lesion was located in a shunt in the moderately tortuous vessel.A 5.0mmx100mmx80cm (4f) sterling balloon catheter was advanced for dilation.However, during the procedure, deflation trouble was encountered.The indeflator was used to deflate the balloon in an inflated state.The patient did not have any symptoms while the balloon remained inflated.The catheter was removed with no patient complications nor injuries were reported.
Event or Problem Description
It was reported that balloon deflation issue occurred.The target lesion was located in a shunt in the moderately tortuous vessel.A 5.0mmx100mmx80cm (4f) sterling balloon catheter was advanced for dilation.However, during the procedure, deflation trouble was encountered.The indeflator was used to deflate the balloon in an inflated state.The patient did not have any symptoms while the balloon remained inflated.The catheter was removed with no patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter stuck inside a merit 6f sheath.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the shaft us stretched 11.2cm and 16.5cm 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: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16025910
• Report Number: 2124215-2022-53017
• Device Sequence Number: 5643020
• Product Code: DQY
• UDI-Device Identifier: 08714729122821
• UDI-Public: 08714729122821
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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: 09/19/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0030134913
• 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: 12/09/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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