MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IDC; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83775
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed on a pusher wire, coil and introducer sheath.The coil and pusher wire arms were not interlocked within introducer sheath.The twist lock of the introducer sheath had been opened.The introducer sheath was inspected, and no anomalies were noted.The pusher wire was inspected, and no anomalies were noticed.The coil was returned kinked and stretched.Functional inspection was performed by advancing the coil through the introducer sheath.However, it was not possible to continue advancing the coil, as the main coil was stuck; it was necessary to cut the sheath in order to release the main coil.Microscopic inspection on pusher wire showed the proximal end had a smooth surface.The pusher wire was inspected, and no damages were noticed.The main coil zap tip also had a smooth surface.The interlocking arm was inspected, and it was found detached.The part was not returned.Dimensional inspection of the pusher wire and main coil that could be measured, were within specification.
Event or Problem Description
Reportable based on device analysis completed on 07may2021.It was reported that coil was stuck inside the catheter.A 3mm x 10cm idc-18 was selected for use.During procedure, it was noted that the coil got stuck inside the renegade catheter.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed a detached interlocking arm.

• Brand Name: IDC
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11917899
• Report Number: 2134265-2021-06969
• Device Sequence Number: 923849
• Product Code: KRD
• UDI-Device Identifier: 08714729158721
• UDI-Public: 08714729158721
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2021

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: 10/04/2023
• Device Model Number: 83775
• Device Catalogue Number: 83775
• Device Lot Number: 0026295203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1