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

Model Number	83786
Medical Device Problem Codes	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	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 15may2024.It was reported that the coil could not be advanced in the catheter.Patient had an abdominal aortic aneurysm and underwent embolization located in a medium tortuous internal iliac artery.A 6f sheath assisted to place angiography catheter and was later followed by a 5f catheter used to guide 12mm x 40cm interlock.035 coil to embolize.During the procedure, there was difficulty advancing after several attempts.When the coil was pulled out, it could not push back again.The delivery was not rotated more than one turn during delivery and the twist lock was not fully opened.After many failed attempts, the device was removed together with the catheter and was replaced for another of the same model to complete the procedure.It was confirmed coil and pusher wire arms were interlocked in the introducer sheath before use and that the sheath was firmly seated in the hub of the catheter before advancing the coil.There were no patient complications reported.However, returned device analysis revealed a detached coil at the arm section.
Additional Manufacturer Narrative
Device evaluated by mfr.: device was returned for analysis.Overall visual revision did not identify failures or evidence that could be lost due to decontamination process.Only the main coil was returned.It was observed that the main coil was bent and stretched at the coil arm, zap tip and primary coil section.Also, the coil arm was detached.The functional could not be performed due only the main coil was returned.The outer diameter (od) of the main coil, zap tip od, and primary coil od passed the dimensional inspection.

• Brand Name: INTERLOCK-35
• 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: 19477211
• Report Number: 2124215-2024-34173
• Device Sequence Number: 3981836
• Product Code: KRD
• UDI-Device Identifier: 08714729792970
• UDI-Public: 08714729792970
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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: 08/22/2026
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0032274768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 56 KG