MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83786
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual inspection was performed and only a coil was returned for this complaint.The coil was inspected and it was found kinked and stretched.The interlocking arm of the coil was detached and it was not returned.Microscopic inspection of the main coil was performed and the zap tip has a smooth surface.Dimensional inspection of the main coil was performed and were within specifications.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2020.It was reported that the coil was stuck in the catheter during delivery.A 6mmx20cm 2d interlock-35 coil was selected for use.During the procedure, after delivering two coils through the.035 4f bern imager catheter, it was noted that half of the coil was delivered to the target vessel.Then, the physician could no longer push.After many images and attempts to use the pusher wire and others, the physician was forced to drag the imager catheter out of the arm to recapture the coil.The procedure was completed with another interlock device.No complications were reported and there were no negative patient consequences.However, device analysis revealed a detached interlocking arm of the coil.

• Brand Name: INTERLOCK-35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11125326
• Report Number: 2134265-2020-18379
• Device Sequence Number: 14391689
• Product Code: KRD
• UDI-Device Identifier: 08714729793021
• UDI-Public: 08714729793021
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2021

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: 09/29/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0026096093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/06/2021
• 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: CATHETER - IMAGER .035 4F BERN
• Patient Age: 15 YR