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
Additional Manufacturer Narrative
Device evaluated by manufacturer: the pusher wire, the introducer sheath and the main coil were returned for analysis.The pusher wire and the main coil were not interlocked.The introducer sheath was inspected, and no anomalies were found.The twist lock of the introducer sheath had been opened.The pusher wire was inspected, and it was found kinked.The main coil was returned kinked and stretched.The proximal end of the pusher wire has a smooth surface.The interlocking arm of the pusher wire was inspected, and no anomalies were noted.The main coil zap tip has a smooth surface and the interlocking arm was detached.The dimensional inspection revealed that the outer diameter (od) at the pusher wire, zap tip and primary coil were found to be within specification.However, there were missing fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 19-apr-2022.It was reported that the coil could not be delivered and was stretched.The target lesion was located in the renal artery.A 6mm x 20cm interlock coil 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 6mm x 20cm coil was deployed, it could not be delivered from the catheter.After repeated attempts, the coil was slowly pulled out and was found to be 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 the interlocking arm got detached and there were 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
• 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: 14345318
• Report Number: 2134265-2022-05052
• Device Sequence Number: 15007139
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: 08714729765004
• 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): 05/10/2022

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: 02/16/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0025372015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2020
• 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