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

Model Number	83779
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The main coil, pusher wire and introducer sheath were returned for this complaint.The main coil and the pusher wire were interlocked within introducer sheath.Introducer sheath was observed, and no damages were noted.The pusher wire was observed, and it was kinked.The main coil was found kinked and severely stretched.The pusher wire was advanced through the introducer sheath, but it was not possible to continue advancing it because the coil was stuck, it was necessary to cut the introducer sheath in order to release the main coil.The zap tip has a smooth surface and the interlocking arm was inspected, and no anomalies was noticed.The proximal end of the pusher wire has a smooth surface.The interlocking arm was inspected, and no anomalies was noticed.Dimensional inspection of the pusher wire pass the overall specification.While for the main coil, the zap tip and the primary coil were within the specification.However, the number of fiber bundles did not match with the specification.
Event or Problem Description
Reportable based on device investigation completed on 01feb2022.It was reported that the device was stuck.The target lesion was located in the internal iliac artery.A 22mm x 60cm pe f-idc interlock embolics was selected for use.During the procedure, it was noted that the device was stuck inside the hub part of the catheter and was removed together with the catheter.The procedure was completed with a different device.There were no complications reported and the patient was fine.However, device investigations revealed that 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: 13592366
• Report Number: 2134265-2022-01663
• Device Sequence Number: 17108870
• Product Code: KRD
• UDI-Device Identifier: 08714729845324
• UDI-Public: 08714729845324
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

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: 10/11/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026334423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER-RENEGADE
• Patient Age: 71 YR
• Patient Sex: Male