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

Model Number	83779
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A pusher wire, coil and introducer sheath were returned for this complaint.The coil returned outside the introducer sheath.The introducer sheath was inspected and no anomalies was noted, the twist lock had been opened.The pusher wire was broken in two parts.The returned coil was kinked.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 was noted.The pusher wire was broken in two parts.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 was noted.Dimensional inspection of the pusher wire and main coil that could be measured were performed and were within specifications.
Event or Problem Description
Reportable based on device analysis completed on 21dec2020.It was reported that the device did not come loose and was stuck.A 10mmx20cm interlock was selected for used.During procedure, the device did not come loose from the lock upon releasing and it was stuck.The procedure was completed with another of the same device.No complications reported and patient was stable.However, device analysis revealed a broken pusher wire.

• 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: 11139036
• Report Number: 2134265-2020-18826
• Device Sequence Number: 16301557
• Product Code: KRD
• UDI-Device Identifier: 08714729765028
• UDI-Public: 08714729765028
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 01/08/2021

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: 02/01/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0023429709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1