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

Model Number	83779
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.Only a coil was returned for this complaint.The coil was inspected, and it was found kinked and severely stretched.The pusher wire and introducer sheath were not returned.No more damages were found in the returned device.Microscopic inspection was performed on the main coil.The zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies was noted.Dimensional inspection on the main coil revealed that the zap tip od (max) outer diameter and primary coil od were within specification.However, the number of fiber bundles were incomplete.
Event or Problem Description
Reportable based on device analysis completed on 22sep2021.It was reported that the device could not be delivered.The target lesion was located in the abdomen area.A 10mm x 50cm interlock coil were selected for use.During the procedure, after the first ring was detached, it was noted that the microcatheter could not be delivered.The device was deployed successfully after replacing the coil with another of the same device.The same problem occurred with the two devices during the operation.No patient complications were reported and the patient was stable post procedure.However, device analysis revealed that the fiber bundles were incomplete.

• 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: 12624969
• Report Number: 2134265-2021-12418
• Device Sequence Number: 1427996
• Product Code: KRD
• UDI-Device Identifier: 08714729845287
• UDI-Public: 08714729845287
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

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: 01/03/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026736005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 55