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 Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A pusher wire, coil and introducer sheath were returned for this complaint.Visual inspection revealed that the coil and pusher wire arms were not interlocked.The twist lock of the introducer sheath had been opened.The coil main was returned kinked and stretched.The pusher wire was found kinked.Functional inspection was performed and revealed that the pusher wire was advanced through the introducer sheath without problems, no resistance was felt.Microscopic inspection of the pusher wire was performed and observed that the proximal end has a smooth surface.The interlocking arm was inspected and no anomalies were noted.Microscopic inspection of the main coil was performed and observed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies were noted.The coil main was found kinked and stretched.Dimensional inspection of the pusher wire that could be measured were performed and were within specifications.Dimensional inspection of the zap tip outer diameter (od), primary coil od of the main coil were performed and were within specifications.Dimensional inspection of the number of coil fiber bundles was performed and revealed that there were lacking fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 09oct2019.It was reported that there was resistance in advancing the coil.The target lesion was located in the internal carotid artery.A 5mmx8cm interlock was selected for use.During procedure, high resistance was felt upon advancing the coil into the lesion and failed to deploy.The coil was then removed together with the catheter from the patient's body, however, it was damaged upon withdrawal.The procedure was completed with another of the same device.No complications reported and patient was stable.However, device analysis revealed 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: 9262481
• Report Number: 2134265-2019-13265
• Device Sequence Number: 11365001
• Product Code: KRD
• UDI-Device Identifier: 08714729764977
• UDI-Public: 08714729764977
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2019

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: 06/03/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0022335270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 56