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

Model Number	83779
Medical Device Problem Codes	Entrapment of Device (1212); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that part of the coil protruded from catheter tip upon removal.The target lesion was in the arteriovenous fistula.A 8mm x 20cm pe f-idc interlock was selected for use.During the procedure, it was noted that the coil was pushed into the microcatheter, a great resistance was felt.The coil could not be pushed out after being pushed halfway.After repeated attempts, it still could not be pushed out into the distal of the catheter.The device was removed from the patient together with the catheter with part of the coil protruding from the catheter tip.It was also found that the coil had been stretched upon removal.The procedure was completed with another of the same device.No complications reported and the patient was in stable condition after procedure.
Event or Problem Description
It was reported that part of the coil protruded from catheter tip upon removal.The target lesion was in the arteriovenous fistula.A 8mm x 20cm pe f-idc interlock was selected for use.During the procedure, it was noted that when the coil was pushed into the microcatheter, a great resistance was felt.The coil could not be pushed out after being pushed halfway.After repeated attempts, it still could not be pushed out into the distal end of the catheter.The device was removed from the patient together with the catheter with part of the coil protruding from the catheter tip.It was also found that the coil had been stretched upon removal.The procedure was completed with another of the same device.No complications were reported and the patient was in stable condition after procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual inspection revealed that only the main coil was returned.It was observed that the main coil was bent and stretched at the primary and zap tip section.Functional testing could not be performed since only the main coil was returned.The coil arm outer diameter (od), zap tip od, and primary coil od passed the dimensional inspection.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18732259
• Report Number: 2124215-2024-06157
• Device Sequence Number: 20319302
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2024

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: 10/24/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030597536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2022
• 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-HIDA ASAHI STD125-26S; MICROCATHETER-HIDA ASAHI STD125-26S
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 65 KG