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

Model Number 83779

Device Problems Break (1069); Separation Failure (2547); Migration (4003)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/04/2020

Event Type  Injury  

Event Description

It was reported that the coil detached, migrated and remained in the peripheral internal iliac artery.The target lesion was located in the moderately tortuous and mildly calcified renal artery.A 10 mm x30 cm interlock coil was selected for use.During procedure, it was noted that the coil was unable to be deployed from the microcatheter.When the physician tried to remove the device together with the microcatheter, the coil became detached and flowed off to the peripheral internal iliac artery.The coil was not retrieved from the patient's body and the procedure was completed with a different device.No further patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that only a pusher wire was returned for this complaint.The pusher wire was inspected and was found kinked, stretched.The interlocking arm was inspected and it was found detached.The detached part was not returned.Microscopic inspection of the pusher wire revealed that the proximal end has a smooth surface.Dimensional inspection of the pusher wire revealed the components were within specification.

Event Description

It was reported that the coil detached, migrated and remained in the peripheral internal iliac artery.The target lesion was located in the moderately tortuous and mildly calcified renal artery.A 10mmx30cm interlock coil was selected for use.During procedure, it was noted that the coil was unable to be deployed from the microcatheter.When the physician tried to remove the device together with the microcatheter, the coil became detached and flowed off to the peripheral internal iliac artery.The coil was not retrieved from the patient's body and the procedure was completed with a different device.No further patient complications were reported.

• 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: 10158483
• MDR Text Key: 195269171
• Report Number: 2134265-2020-08036
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729765035
• UDI-Public: 08714729765035
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0024089046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 07/07/2020
• Supplement Dates FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other