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

Model Number	M001361600
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the main coil, the introducer sheath and the pusher wire were returned for evaluation.Visual inspection revealed that the pusher wire was detached at the distal solder joint section, also the coil section was bent and stretched.The main coil was bent and stretched at the coil arm and primary coil section, moreover the arm coil was detached.Microscopic inspection revealed that the main coil was detached, bent and stretched.Dimensional inspection of the main coil and pusher wire revealed the components were within specifications.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 01apr2025.It was reported that coil was unable to advance in the microcatheter.A 10mm x 30cm interlock was selected for use in a pulmonary arteriovenous fistula.During the procedure, when the coil was pushed to about 1/3 of the non-boston scientific microcatheter, the coil could not be pushed and was difficult to withdraw.Repeated adjustment resulted in premature deployment of the coil inside the catheter.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed arm coil detachment.

• 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: 21902471
• Report Number: 2124215-2025-25313
• Device Sequence Number: 4085307
• Product Code: KRD
• UDI-Device Identifier: 08714729765035
• UDI-Public: (01)08714729765035(17)260815(10)32435605
• 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): 04/24/2025

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: 08/15/2026
• Device Model Number: M001361600
• Device Catalogue Number: M001361600
• Device Lot Number: 0032435605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: TERUMO 2.4F
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 80 KG