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

Model Number	83779
Medical Device Problem Codes	Break (1069); Separation Failure (2547); Migration (4003)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/04/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10158483
• Report Number: 2134265-2020-08036
• Device Sequence Number: 17091758
• Product Code: KRD
• UDI-Device Identifier: 08714729765035
• UDI-Public: 08714729765035
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other