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	08/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil protruded from the catheter tip upon removal.A 2mm x 4cm interlock was selected for use in a vascular embolization procedure to treat duodenal bleeding.The anatomy was severely tortuous.During the procedure, it was noted that the coil became stuck in the distal part of the catheter and protruded from the catheter tip.The coil was removed together with the catheter.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A pusher wire, introducer sheath and coil were returned for this complaint.The coil and pusher wire arms were interlocked within introducer sheath.The pusher wire was inspected, and no issues was noted.The coil was inspected, and no damages were found.No more damages were found in the returned device.The pusher wire was advanced through the introducer sheath, but it was not possible to continue advancing it because the coil was stuck, it was necessary to cut the introducer sheath in order to release the main coil.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.Dimensional inspection of the pusher wire and main coil that could be measured were performed and were within specifications.
Event or Problem Description
It was reported that the coil protruded from the catheter tip upon removal.A 2mm x 4cm interlock was selected for use in a vascular embolization procedure to treat duodenal bleeding.The anatomy was severely tortuous.During the procedure, it was noted that the coil became stuck in the distal part of the catheter and protruded from the catheter tip.The coil was removed together with the catheter.The procedure was completed with a different device.No patient complications were reported.

• 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: 12413878
• Report Number: 2134265-2021-11014
• Device Sequence Number: 14346851
• Product Code: KRD
• UDI-Device Identifier: 08714729845263
• UDI-Public: 08714729845263
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/04/2021

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: 02/28/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027058782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 10/04/2021
• 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-CARNELIAN SI; CATHETER-CARNELIAN SI; CATHETER-CARNELIAN SI