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

Model Number	83779
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 13apr2022.It was reported that the coil could not be delivered and was stretched.The target lesion was located in the renal artery.A 8mmx20cm interlock was selected for use.During the procedure, a microcatheter was used to deploy a 10mmx20cm and a 8mmx20cm 18-coil and both were deployed normally.However, when the 8x20cm 18-coil was deployed, it could not be delivered from the catheter.After repeated attempts, the coil was pulled out and was found stretched and damaged.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, device analysis revealed that there were missing fiber bundles.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The introducer sheath, the main coil and the pusher wire were returned.The introducer sheath was inspected, and no damages were noted.The twist lock was opened.The main coil and the pusher wire were not interlocked inside the introducer sheath.The main coil was kinked and stretched.The pusher wire was bent.The zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies were noted.The dimensional inspection revealed that the outer diameter (od) at the zap tip and pusher wire were found to be within specification.However, the outer diameter (od) of the primary coil was found stretched.Also, the number of fiber bundles were missing.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14293773
• Report Number: 2134265-2022-04861
• Device Sequence Number: 5408886
• Product Code: KRD
• UDI-Device Identifier: 08714729765011
• UDI-Public: 08714729765011
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2022

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: 02/14/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026980387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 81 KG