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

Model Number	83779
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that a pusher wire, introducer sheath and main coil were returned for this complaint.The coil and pusher wire arms were not interlocked within introducer sheath.An important amount of blood was noticed inside introducer sheath, no damages were found.The coil was inspected, and it was found kinked and severely stretched.The pusher wire was inspected, it was kinked.The zap tip of the coil is broken, it seems to be only the half of it still attached to the coil.No more damages were found in the returned device.The pusher wire was advanced through the introducer sheath, but it was not possible to continue advancing it because the coil was stuck, it was necessary to cut the introducer sheath in order to release the main coil.Microscopic inspection of the pusher wire revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies was noted.Microscopic inspection of the main coil revealed that the zap tip was damaged (it seems to be broken).The interlocking arm was inspected, and it was detached.Dimensional inspection of the pusher wire and main coil revealed the components were within specification except the number of fiber bundles, which were only 11 out of 20.The fiber loss was due to coil's stretched condition.
Event or Problem Description
Reportable based on device analysis completed on 07oct2021.It was reported that resistance was felt in the dispenser.The target lesion was located in the moderately tortuous and non-calcified subclavian artery.A 10mm x 50cm interlock 2d was selected for use.During the procedure, it was noted that resistance was felt in the dispenser.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the interlocking arm was detached and there were missing fiber bundles.

• 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: 12697539
• Report Number: 2134265-2021-12981
• Device Sequence Number: 14564140
• Product Code: KRD
• UDI-Device Identifier: 08714729845287
• UDI-Public: 08714729845287
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/26/2021

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: 01/03/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026736065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1