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

Model Number	83779
Medical Device Problem Codes	Entrapment of Device (1212); Premature Activation (1484); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil protruded from the catheter's tip during removal.The target lesion was located in the splenic artery.A 12mm x 20cm interlock coil was selected for use.During the procedure, resistance was felt upon deployment.Subsequently, when the physician, tried to remove the device, the coil got detached from the interlocking arm of the pusher wire.The device was then removed through the sheath and it was noted that the coil protruded from the catheter's tip.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
B3: event date - 09/13/21.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.A valve, the main coil, pusher wire, and introducer sheath were returned for this complaint.The pusher wire and coil were interlock inside the introducer sheath.The twist lock of the introducer sheath was found opened.The introducer sheath was inspected, and no anomalies was noted.The pusher wire was inspected.No anomalies were noticed.The coil was inspected, and it was kinked and stretched.Functional inspection was performed.The main coil was advanced through the introducer sheath without problems, no resistance was felt.Microscopic inspection on pusher wire revealed that the proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies were noticed.Microscopic inspection on main coil revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies was noticed.The dimensional inspection of the pusher wire revealed that the device was within specification.
Event or Problem Description
It was reported that the coil protruded from the catheter's tip during removal.The target lesion was located in the splenic artery.A 12mm x 20cm interlock coil was selected for use.During the procedure, resistance was felt upon deployment.Subsequently, when the physician, tried to remove the device, the coil got detached from the interlocking arm of the pusher wire.The device was then removed through the sheath and it was noted that the coil protruded from the catheter's tip.The procedure was completed with another of same device.No patient complications were reported and 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: 12590738
• Report Number: 2134265-2021-12251
• Device Sequence Number: 11857201
• Product Code: KRD
• UDI-Device Identifier: 08714729765042
• UDI-Public: 08714729765042
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: 01/03/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0025145913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/09/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 64