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

Model Number	83779
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection performed on pusher wire, coil and introducer sheath were returned for this complaint.The twist lock of the introducer sheath had been opened.The introducer sheath was inspected and no anomalies was noted.Residues of blood were noted within the introducer sheath.The coil fiber bundles had blood on them.The pusher wire was inspected and no anomalies was noted.The coil was returned kinked and stretched.No more damages were found in the returned device.Functional inspection performed on pusher wire was advanced through the introducer sheath, but it was not possible to continue advancing it due to the main coil was stuck; it was necessary to cut the sheath in order to release the main coil.After the main coil was release it was noted that the interlocking arm was detached.The coil was returned kinked and stretched.Microscopic inspection performed on pusher wire.The proximal end has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Microscopic inspection performed on main coil.The zap tip has a smooth surface.The interlocking arm was inspected and it was detached.Dimensional inspection of the pusher wire that could be measured were performed and were within specification.Dimensional inspection of the main coil was performed and revealed that the outer diameter (od) of the zap tip and primary coil were within specification.However, the were missing number of fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 23oct2020.It was reported that the coil stuck in the catheter.A 14mmx20cm interlock was selected for use in a bronchial artery embolization procedure.During procedure, the coil was deployed but it got stuck.The microcatheter was then retrieved.The procedure was completed with a another of the same device.No complications reported and patient was stable post procedure.However, device analysis revealed detached interlocking arm and missing fiber bundles.

• 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: 10825137
• Report Number: 2134265-2020-15603
• Device Sequence Number: 14191452
• Product Code: KRD
• UDI-Device Identifier: 08714729765066
• UDI-Public: 08714729765066
• 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): 11/11/2020

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: 07/28/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0022574585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 65