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

Model Number	83779
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 01-apr-2024.It was reported that failure to advance in the catheter and premature deployment inside the patient occurred.The patient underwent endovascular aneurysm repair of the target lesion located in the internal iliac artery.During the procedure, a 22mm x 60cm interlock was loaded and pushed into a 2.0fr non-boston scientific microcatheter.Arm-locking was released inside the microcatheter; however, the coil could not be pushed out despite several attempts.The entire catheter was removed from the patient's body.The procedure was completed with another of same device.There were no complications reported and the patient condition was fine.However, returned device analysis revealed that the arm coil was detached.
Additional Manufacturer Narrative
Unit returned with its original pouch, and overall visual revision did not identify failures or evidence that could be lost due to decontamination process.It was observed that the main coil and the pusher wire were returned.It was observed that the main coil was bent and stretched at the coil arm and zap tip section, also the arm coil was detached.The functional could not be performed due the main coil and the pusher wire are not interlocking.

• 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: 19164697
• Report Number: 2124215-2024-20957
• Device Sequence Number: 7855562
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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: 03/13/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027132718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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: TERUMO PROGREAT 2.0FR.
• Patient Age: 84 YR
• Patient Sex: Male