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

Model Number	83779
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based device analysis completed on 05feb2024.It was reported that advancing issue occurred.The target lesion was located in the iliac artery.A 12mm x 20cm interlock 2d coil was selected for use.During the procedure, the coil was advanced into the body through 18f microcatheter.However, resistance occurred in the tortuous lesion.The physician recaptured the coil and advanced again, but still could not push the device.The coil and catheter were removed together, and the procedure was completed with a new coil.No complications were reported, and the patient was stable.However, device analysis revealed main coil arm detachment.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6) hospital, (b)(6).Device evaluated by mfr.: the device was returned for analysis.Visual inspection was observed that the main coil, the introducer sheath and the pusher wire were returned.It was observed that the main coil was bent and stretched at the coil arm, zap tip and primary coil section.Also, the arm coil was detached.A part of the original box was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed.Functional inspection could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection of the main coil zap tip outer diameter (od) and primary coil od pass the test.

• 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: 18768624
• Report Number: 2124215-2024-08213
• Device Sequence Number: 15388377
• Product Code: KRD
• UDI-Device Identifier: 08714729765042
• UDI-Public: 08714729765042
• 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
• Report Date (Section B): 02/23/2024

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: 08/29/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030244192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 85 KG