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

Model Number	83779
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A pusher wire, coil, hoop and introducer sheath were returned.Besides, a rhv was returned.The coil and pusher wire arms were interlocked within introducer sheath.The twist lock of the introducer sheath had been opened.Residues of blood were noted within the introducer sheath.The coil fiber bundles had blood on them.The introducer sheath was inspected and no anomalies were noted.The pusher wire was advanced through the introducer sheath without problems.No resistance was felt.The proximal end of the pusher wire has a smooth surface.The pusher wire was inspected and was found kinked and damaged.The interlocking arm of the pusher wire was inspected and no anomalies were noted.The main coil zap tip was detached.The interlocking arm was inspected and no anomalies were noted.A dimensional inspection revealed that the outer diameter (od) of pusher wire, primary coil and no.Of fiber bundles were within specification.
Event or Problem Description
Reportable based on device analysis completed on 23dec2019.It was reported that difficulty advancing the coil through the guide catheter occurred.The target lesion area was located in the proximal and middle left anterior descending (lad) artery.A 3mm x 6cm interlock was selected for use.During the procedure, guidewires were inserted deeply into coronary artery through the guiding catheter.Force was used to deliver the guide catheter.The coil could not reach the spiral fistula through the micro catheter.The physician tried to cut, but it failed to reach to the fistula part.Another of the same device was selected but also failed.The coil was removed within the catheter all together.The procedure was completed with another of the same device.No complications reported, and the patient was stable.However, device analysis revealed a detached zap tip.

• 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: 9582122
• Report Number: 2134265-2019-16701
• Device Sequence Number: 10856172
• Product Code: KRD
• UDI-Device Identifier: 08714729764939
• UDI-Public: 08714729764939
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2020

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: 03/18/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0023665586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR