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 Consequences Or Impact To Patient (2199)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the device was returned for analysis.A pusher wire, introducer sheath and coil were returned for this complaint.Visual inspection was performed and revealed that the twist lock of the introducer sheath had been opened.The introducer sheath was inspected and no anomalies was noted.The coil and pusher wire were returned stretched and kinked.The interlocking arms were inspected and it was detached from the rest of the coil and pusher wire.Microscopic inspection of the pusher wire was performed and revealed that the proximal end has a smooth surface.The interlocking arm was inspected and it was detached from the rest of the pusher wire, in addition it was not returned.Microscopic inspection of the main coil and revealed that the proximal end has a smooth surface.The interlocking arm was inspected and it was detached from the rest of the coil, in addition it was not returned.Dimensional inspection of the mid solder joint outer diameter (od), distal tfe od., and proximal tfe od were performed and were within specifications.Dimensional inspection of the main coil zap tip od and primary coil od were performed and were within specifications.However, dimensional inspection of the number of fiber bundles revealed fiber loss and does not meet specification.The fiber loss was due to the coil condition.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 16nov2020.It was reported that the coil was stuck in the catheter.A 10mmx50cm interlock coil was selected for use on the internal iliac artery.During the procedure, it was noted that the coil was stuck in the catheter distal part.The coil was removed with the catheter and the procedure was completed with another of the same device.No complications were reported and there was no patient injury.However, device analysis revealed an interlocking arm detached from the rest of the coil and pusher wire, and fiber loss.

• 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: 10920346
• Report Number: 2134265-2020-16411
• Device Sequence Number: 2465663
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2020

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: 08/02/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0025952120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICRO CATHETER - RENEGADE STC18