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

Model Number	83779
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6)2024.It was reported that the coil could not be advanced in the catheter and could not be withdrawn.The target lesion was located in a transjugular intraheptic portosystemic shunt (tips) in the mildly tortuous fundus gastric vein.A 6mm x 20cm and 8mm x 20cm interlock coils were used.During the procedure, heparin saline was continuously injected.After each coil was introduced into a 2.7fr microcatheter, it could not be advanced in after crossing the midline and could not be withdrawn from the microcatheter.The coils removed together with the catheter.The procedure was completed with new 6mm x 20cm and 8mm x 20cm coils.There were no patient complications reported and the patient status was stable.However, device analysis revealed that the coil arm was detached.
Additional Manufacturer Narrative
The device was returned for analysis.During visual inspection, it 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 primary coil section.The pusher wire was bent at heat shrink tfe tubing and also the coil was bent, stretched and the arm was detached.The functional inspection could not be performed due the main coil and the pusher wire are not interlocking.Based on the evidence, the reported issues could be confirmed due the device condition.

• 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: 19667188
• Report Number: 2124215-2024-40886
• Device Sequence Number: 6848101
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: 08714729765004
• 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): 07/03/2024

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: 08/21/2026
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0032472057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 80 KG