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

Model Number	83779
Medical Device Problem Codes	Separation Failure (2547); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the abdominal aortic aneurysm.A 14mmx30cm interlock was selected for use.During the procedure, it was noted that the coil could not be released through the microcatheter and failed to deploy.The coil was simply pulled out with microcatheter and the procedure was cancelled.No patient complications were reported and patient was stable post procedure.
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the abdominal aortic aneurysm.A 14mmx30cm interlock was selected for use.During the procedure, it was noted that the coil could not be released through the microcatheter and failed to deploy.The coil was simply pulled out with microcatheter and the procedure was cancelled.No patient complications were reported and patient was stable post procedure.It was further reported that according to plan, the physician was ready to deploy 2 coils.However, due to the issue noted on the second coil, only one coil was actually deployed.
Additional Manufacturer Narrative
Device evaluated by mfr.: the complaint device was returned for analysis.During media analysis it was noticed that a customer has attached a photo of the coil, it can be observed that the main coil is kinked and severely stretched, also, there is a video attached that shows an x-ray media.Visual inspection, only a main coil and introducer sheath were returned for this complaint.The main coil was severely stretched, and kinked, interlocking arm was detached.The introducer sheath was inspected, and no anomalies were noticed.No more damages noticed.Microscopic inspection on main coil, the zap tip has a smooth surface.The interlocking arm was inspected, and it was detached (part was not returned).Dimensional inspection shows fiber loss due to coil stretching condition.
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the abdominal aortic aneurysm.A 14mmx30cm interlock was selected for use.During the procedure, it was noted that the coil could not be released through the microcatheter and failed to deploy.The coil was simply pulled out with microcatheter and the procedure was cancelled.No patient complications were reported and patient was stable post procedure.It was further reported that according to plan, the physician was ready to deploy 2 coils.However, due to the issue noted on the second coil, only one coil was actually deployed.

• 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: 12053978
• Report Number: 2134265-2021-08075
• Device Sequence Number: 4423917
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026621147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 06/28/2021; 08/09/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/12/2021; 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 60