MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83786
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual inspection was performed.Only the main coil was returned.The main coil was stretched and kinked.No more damages were found.Microscopic inspection was performed on main coil.The zap tip has a smooth surface.The interlocking arm was detached.Dimensional inspection on main coil was performed and revealed that the od (outer diameter) of the zap tip and primary coil were within specification.However, the no.Of distal fiber bundles and no.Of proximal fiber bundles were incomplete.
Event or Problem Description
Reportable based on device analysis completed on 15jun2022.It was reported that the coil got stuck in the catheter.The target lesion was located in the abdominal aorta and internal iliac artery.An 8mm x 40cm and 10mm x 20cm interlock-35 coil were selected for use.During the procedure, three interlocks were placed smoothly.However, when the fourth catheter was pushed, it got stuck near the middle of the catheter.The coil was removed together with the entire catheter from the body.A new interlock was inserted together with the same catheter and completed the procedure.Two interlocks were implanted into the body.No patient complications were reported.However, the device analysis revealed that the interlocking arm was detached and the fiber bundles were missing.

• Brand Name: INTERLOCK-35
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14959441
• Report Number: 2134265-2022-07624
• Device Sequence Number: 20182489
• Product Code: KRD
• UDI-Device Identifier: 08714729793137
• UDI-Public: 08714729793137
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133208
• 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): 07/08/2022

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: 09/11/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0024418043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2019
• 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: GUIDE CATHETER - 0.038 IMPRESS.
• Patient Sex: Prefer Not To Disclose