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

Model Number	83777
Medical Device Problem Codes	Premature Activation (1484); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that the pusher wire and the coil were returned.The pusher wire was inspected and it was kinked the main coil was inspected and it was kinked/stretched.Microscopic inspection revealed the proximal end of the pusher wire has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Inspection of the main coil revealed the zap tip has a smooth surface and the interlocking arm was inspected and no anomalies was noted.Dimensional inspection of the main coil revealed that the zap tip overall dimension (od) and the primary coil matches the specification while the number of fiber bundles do not match the specification.The fiber loss were out of specification due to the coil condition.For the pusher wire, the distal solder (od), mid solder (od), distal tfe (od) and proximal tfe (od) all matches the specification.
Event or Problem Description
Reportable based on device analysis completed on 28sep2020.It was reported that the coil deployed prematurely.The target lesion area was located in the coronary artery.A 2/6mm x 8 cm interlock embolic was selected for use in a congenital coronary arteriovenous fistula.During the procedure, the coil was pushed into the microcatheter and the deployment was not suitable.The guidewire and coil was retrieved, but the coil was not found.Lately, it was noted that the coil deployed inside the microcatheter and the interlocking detachable arms were damaged.The coil was simply pulled out with the catheter.The procedure was completed with another of the same device.No patient complications reported.However, device investigation revealed 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: 10616963
• Report Number: 2134265-2020-13532
• Device Sequence Number: 11514235
• Product Code: KRD
• UDI-Device Identifier: 08714729765110
• UDI-Public: 08714729765110
• 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): 10/01/2020

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: 02/03/2021
• Device Model Number: 83777
• Device Catalogue Number: 83777
• Device Lot Number: 0021822610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/01/2020
• 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: 70