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

Model Number	83779
Medical Device Problem Codes	Material Integrity Problem (2978); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a coil migration occurred.A 20mmx50cm 2d interlock coil was selected for use on the renal artery.During the procedure, it was noted that the coil was not fully deployed inside the patient's body and was washed away.It took the physician two more hours to refloat the coil.The device was removed and the procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.
Event or Problem Description
It was reported that a coil migration occurred.A 20mmx50cm 2d interlock coil was selected for use on the renal artery.During the procedure, it was noted that the coil was not fully deployed inside the patient's body and was washed away.It took the physician two more hours to refloat the coil.The device was removed and the procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.It was further reported that a snare was used to removed the coil.The physician thought that the coil migration was due to blood flow velocity.
Event or Problem Description
It was reported that a coil migration occurred.A 20mmx50cm 2d interlock coil was selected for use on the renal artery.During the procedure, it was noted that the coil was not fully deployed inside the patient's body and was washed away.It took the physician two more hours to refloat the coil.The device was removed and the procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.It was further reported that a snare was used to removed the coil.The physician thought that the coil migration was due to blood flow velocity.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A main coil was returned for this complaint.Visual inspection was performed and revealed that the coil fiber bundles have blood.The main coil is kinked and stretched.Microscopic inspection of the main coil was performed and revealed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Dimensional inspection of the main coil was performed and the measured dimensions were within specification.No other issues were identified during the product analysis.

• 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: 11049506
• Report Number: 2134265-2020-17353
• Device Sequence Number: 19091085
• Product Code: KRD
• UDI-Device Identifier: 08714729845317
• UDI-Public: 08714729845317
• 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,Followup
• Report Date (Section B): 01/19/2021

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: 01/05/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0023295875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 12/23/2020; 01/13/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 01/06/2021; 01/19/2021
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 62