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

Model Number 83786

Device Problems Break (1069); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2020

Event Type  malfunction  

Event Description

It was reported that the coil was detached and severely fractured and had to be removed with forceps.The target lesion was in the pulmonary artery.A 8mm x 40cm interlock-35 coil was selected for use.During advancement of the delivery system, the physician heard a clicking sound and could not advance the delivery system, so he asked to stop advancing.The physician withdrew the delivery system outside the y-valve and found that the coil detached.The physician placed the tail end of the 5f contrast tube under the radiation and found that the detached part was located at the tail end.The physician unscrewed the y-valve, removed the coil with forceps, and observed that several parts of the detached part were severely fractured.The physician manually restored the lock and withdrew into the transparent protective sheath for reoperation.The procedure was completed with another of same device.No further patient complications were reported and patient was stable post procedure.

Event Description

It was reported that the coil was detached and severely fractured and had to be removed with forceps.The target lesion was in the pulmonary artery.A 8mm x 40cm interlock-35 coil was selected for use.During advancement of the delivery system, the physician heard a clicking sound and could not advance the delivery system, so he asked to stop advancing.The physician withdrew the delivery system outside the y-valve and found that the coil detached.The physician placed the tail end of the 5f contrast tube under the radiation and found that the detached part was located at the tail end.The physician unscrewed the y-valve, removed the coil with forceps, and observed that several parts of the detached part were severely fractured.The physician manually restored the lock and withdrew into the transparent protective sheath for reoperation.The procedure was completed with another of same device.No further patient complications were reported and patient was stable post procedure.It was further reported that continuous flushing was performed prior to the introduction of the coil.The physician cannot manually restore the lock and withdrew into the transparent protective sheath for reoperation.The coil was simply pulled out and there was no fragment left inside the patient's body.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.Only a delivery wire was returned and it inspected and no damages was found.Microscopic inspection of the delivery wire revealed that the proximal end has a smooth surface.The interlocking arm was inspected and no damages was found.Dimensional inspection of the delivery wire revealed the components were within specification.

Event Description

It was reported that the coil was detached and severely fractured and had to be removed with forceps.The target lesion was in the pulmonary artery.A 8mm x 40cm interlock-35 coil was selected for use.During advancement of the delivery system, the physician heard a clicking sound and could not advance the delivery system, so he asked to stop advancing.The physician withdrew the delivery system outside the y-valve and found that the coil detached.The physician placed the tail end of the 5f contrast tube under the radiation and found that the detached part was located at the tail end.The physician unscrewed the y-valve, removed the coil with forceps, and observed that several parts of the detached part were severely fractured.The physician manually restored the lock and withdrew into the transparent protective sheath for reoperation.The procedure was completed with another of same device.No further patient complications were reported and patient was stable post procedure.It was further reported that continuous flushing was performed prior to the introduction of the coil.The physician cannot manually restore the lock and withdrew into the transparent protective sheath for reoperation.The coil was simply pulled out and there was no fragment left inside the patient's body.

• Brand Name: INTERLOCK-35
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10922804
• MDR Text Key: 218966158
• Report Number: 2134265-2020-16570
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: 08714729793014
• Combination Product (y/n): N
• PMA/PMN Number: K133208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0025605875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 62