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

Model Number	83779
Medical Device Problem Codes	Premature Activation (1484); Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that coil migrated outside of the renal artery and was removed with a gripper.A 14mmx30cm interlock coil was selected for use in a renal aneurysm.During procedure, the coil released halfway and slipped out of the renegade stc 18 microcatheter into the patient's renal artery.When confirming the coil position during angiography, it was found that the coil was outside the patient's renal aneurysm.The microcatheter was withdrawn, the 6f non bsc sheath was replaced, and the coil was completely removed from the patient's body using a gripper.The procedure was completed with additional coils.No further patient complications were reported and patient was stable post procedure.
Event or Problem Description
It was reported that coil migrated outside of the renal artery and was removed with a gripper.A 14mmx30cm interlock coil was selected for use in a renal aneurysm.During procedure, the coil released halfway and slipped out of the renegade stc 18 microcatheter into the patient's renal artery.When confirming the coil position during angiography, it was found that the coil was outside the patient's renal aneurysm.The microcatheter was withdrawn, the 6f non bsc sheath was replaced, and the coil was completely removed from the patient's body using a gripper.The procedure was completed with additional coils.No further patient complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Device evaluated by mfr: the device was returned for evaluation.Only the coil main was returned for this complaint.The coil was returned kinked and it has dried blood.No more damages were found in the returned device.The zap tip has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Dimensional inspection of the main coil revealed the components were within specifications.

• 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: 10116943
• Report Number: 2134265-2020-07421
• Device Sequence Number: 16606468
• Product Code: KRD
• UDI-Device Identifier: 08714729765073
• UDI-Public: 08714729765073
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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: 07/22/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0024309096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER SHEATH: 6F COOK SHEATH; INTRODUCER SHEATH: 6F COOK SHEATH; MICROCATHETER: RENEGADE STC 18; MICROCATHETER: RENEGADE STC 18
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR