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

Model Number 83779

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 336983610
• Report Number: 2124215-2024-08213
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 85 KG