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	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery (lad).A 4.0mmx100mmx135cm sterling balloon catheter was advanced to treat the lesion.However, during the procedure, the device became stuck with a 300cm non- boston scientific guidewire.The device was removed as one unit and the procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
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 and microscopic examination revealed no damages.Device to device interaction was performed by tracking the device over a test guidewire.There were no issues tracking.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that catheter entrapment occurred.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery (lad).A 4.0mmx100mmx135cm sterling balloon catheter was advanced to treat the lesion.However, during the procedure, the device became stuck with a 300cm non- boston scientific guidewire.The device was removed as one unit and the procedure was completed with a different device.No patient complications were reported.

• 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: 15688259
• Report Number: 2124215-2022-42578
• Device Sequence Number: 15295723
• Product Code: DQY
• UDI-Device Identifier: 08714729123507
• UDI-Public: 08714729123507
• 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): 12/01/2022

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: 01/13/2024
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0026625581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: JUPITER FC3 300CM.; GUIDE WIRE: JUPITER FC3 300CM.
• Patient Sex: Unknown