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

Model Number	83779
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the complaint device was returned for analysis.Visual inspection, a pusher wire, and main coil were returned inside a catheter.Blood was noticed in the device.The main coil and pusher wire were not interlocked.The pusher wire was inspected and was found kinked.The coil was returned stretched and kinked.No more damages were found in the returned device.Microscopic inspection of the pusher wire.The proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies was noted.Main coil, the zap tip was inspected, and it was detached.The interlocking arm was inspected, and it was detached.The dimensions that could be measured were within specification.
Event or Problem Description
Reportable based on device analysis completed 19aug2021.It was reported that coil friction occurred.The target lesion was located in the spleen artery aneurysm.A 10mm x 30cm 2d interlock coil was selected was use.During the procedure, the coil could not be inserted into the non-boston scientific microcatheter.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine post procedure.However, returned device analysis revealed coil detachment.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12451010
• Report Number: 2134265-2021-11053
• Device Sequence Number: 14307822
• Product Code: KRD
• UDI-Device Identifier: 08714729765035
• UDI-Public: 08714729765035
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K132578
• 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
• Report Date (Section B): 09/09/2021

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: 02/21/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027017435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1