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

Model Number 83779

Device Problems Entrapment of Device (1212); Premature Activation (1484); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2021

Event Type  malfunction  

Event 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.

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 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
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12590738
• MDR Text Key: 275191748
• Report Number: 2134265-2021-12251
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729765042
• UDI-Public: 08714729765042
• Combination Product (y/n): N
• PMA/PMN Number: K132578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 64