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

Model Number	83779
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic inspection revealed that the main coil, pusher wire, hoop and introducer sheath were returned for this complaint.The pusher wire and introducer sheath were returned inside the hoop.The main coil was inspected and was found stretched near to the interlocking arm section.The main coil zap tip has a smooth surface.The pusher wire was inspected and was found kinked in different sections.The proximal end has a smooth surface.The interlocking arm was inspected and no anomalies were noted.No more damages were found in the returned device.The dimensional inspection revealed that the pusher wire and the main coil where within its specification aside from the missing number of fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 30apr2020.It was reported that the interlocking arms could not deploy.The target lesion was located in the splenic artery.A 3mm x 12cm interlock coil was selected for use in the embolization of ruptured splenic aneurysm for severe abdominal pain.During procedure, a bsc microcatheter was advanced into the splenic aneurysm for blood supply angiography.The coil was used for embolization, however the interlocking detachable arms could not deploy after entering into the vessel.Then, it was withdrawn and was tried in the microcatheter.Subsequently, upon advancement of the coil for repositioning, the interlocking arms still could not deploy after being flushed with saline.However, it was further reported that continuous flushing was performed.The device was removed and completed the procedure with another of same device.There were no patient complications reported and patient was stable post procedure.However, device analysis revealed missing fiber bundle.

• 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: 10021517
• Report Number: 2134265-2020-05917
• Device Sequence Number: 16822988
• Product Code: KRD
• UDI-Device Identifier: 08714729764946
• UDI-Public: 08714729764946
• 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
• Report Date (Section B): 05/04/2020

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: 01/22/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0023385358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 65