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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil protruded in the catheter's tip during removal.A 18mmx50cm 2d interlock coil was selected for embolization of a splenic aneurysm.During the procedure, the coil was connected and pushed a third of the coil through the microcatheter, but it could not be pushed further, and could not be recaptured.It was noted that the coil became stuck and protruded from the catheter tip when removed.The coil and the microcatheter were simply pulled out together and the procedure was completed with another of the same device.No complications were reported and the patient was stable post-procedure.
Event or Problem Description
It was reported that the coil protruded in the catheter's tip during removal.A 18mmx50cm 2d interlock coil was selected for embolization of a splenic aneurysm.During the procedure, the coil was connected and pushed a third of the coil through the microcatheter, but it could not be pushed further, and could not be recaptured.It was noted that the coil became stuck and protruded from the catheter tip when removed.The coil and the microcatheter were simply pulled out together and the procedure was completed with another of the same device.No complications were reported and the patient was stable post-procedure.
Additional Manufacturer Narrative
Correction to bsc aware date: updated from 05/24/2021 to 05/19/2021.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Only the pusher wire was returned for this complaint.The pusher wire was visually inspected, and it was found kinked.No more damages were found in the device.Microscopic inspection of the pusher wire was performed and revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies was noted.Dimensional inspection of the pusher wire was performed and the measured dimensions were within specification.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the coil protruded in the catheter's tip during removal.A 18mmx50cm 2d interlock coil was selected for embolization of a splenic aneurysm.During the procedure, the coil was connected and pushed a third of the coil through the microcatheter, but it could not be pushed further, and could not be recaptured.It was noted that the coil became stuck and protruded from the catheter tip when removed.The coil and the microcatheter were simply pulled out together and the procedure was completed with another of the same device.No complications were reported and the patient was stable post-procedure.

• 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: 11995573
• Report Number: 2134265-2021-07222
• Device Sequence Number: 922872
• Product Code: KRD
• UDI-Device Identifier: 08714729845300
• UDI-Public: 08714729845300
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2021

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: 06/03/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0024059376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 05/19/2021; 07/09/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 06/17/2021; 07/26/2021
• 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: MICROCATHETER - RENEGADE STC18; MICROCATHETER - RENEGADE STC18; MICROCATHETER - RENEGADE STC18; MICROCATHETER - RENEGADE STC18
• Patient Age: 70 YR
• Patient Weight: 75