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

Model Number	83779
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A coil and introducer sheath were returned for this complaint.The pusher wire and rhv were not returned.The coil was returned tied with a nylon thread.The twist lock of the introducer sheath had been opened.The introducer sheath was inspected and no anomalies were noted.The coil was returned stretched and kinked near the interlocking arm.The interlocking arm was inspected and was found kinked.No more damages were found in the returned device.Microscopic inspection of the main coil revealed that the zap tip has a smooth surface.The coil was returned stretched and kinked near the interlocking arm.The interlocking arm was inspected and was found kinked.Dimensional inspection of the outer diameter (od) of zap tip, od of the primary coil were performed and were within specifications.Dimensional inspection of fiber bundles was performed and revealed missing fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 20jan2020.It was reported that the coil failed to fill in liquid.The target lesion was located in the coronary artery fistula.During the procedure, it was noted that the coil failed to fill in liquid.The procedure was completed with another of the same device.No complications reported and patient's condition was stable.However, device analysis revealed missing coil 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: 9694788
• Report Number: 2134265-2020-01251
• Device Sequence Number: 1809894
• Product Code: KRD
• UDI-Device Identifier: 08714729764984
• UDI-Public: 08714729764984
• 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): 02/11/2020

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: 12/03/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0023132271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 70