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

Model Number	83779
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the device was returned for evaluation.A pusher wire and the coil were returned for this complaint; the introducer sheath was not returned.The coil and pusher wire were not interlocked.The pusher wire was inspected and it was found kinked near the interlocking arm.The coil was inspected and was found stretched near to the interlocking arm.The proximal end has a smooth surface.The wire was found kinked near the interlocking arm.The interlocking arms were inspected and no anomalies were noted.The zap tip has a smooth surface.Dimensional inspection of the pusher wire and main coil revealed the components were within specification except the number of fiber bundles, which were only 27 out of 30.
Event or Problem Description
Reportable based on device analysis completed on 07may2020.It was reported that the coil was twisted and could not be delivered into the microcatheter.The 100% stenosed target lesion was located in the moderately tortuous and non calcified brachiocephalic artery.A 12mmx30cm interlock coil was selected for use.During the procedure, it was noted that the coil could not be delivered into the microcatheter.The coil was torqued or twisted due to excessive rotation of the twist lock to unlock it.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that 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: 10065675
• Report Number: 2134265-2020-06620
• Device Sequence Number: 14396743
• Product Code: KRD
• UDI-Device Identifier: 08714729765059
• UDI-Public: 08714729765059
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2020

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: 12/31/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0023272926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1