MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Interlock?; device, vascular, for promoting embolization

Model Number	M001361920
Medical Device Problem Codes	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	06/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 01sep2026.It was reported that the coil was unable to advance and withdraw from the microcatheter.A 10mm x 50cm interlock coil was selected for use.However, during the procedure, it was noted that the coil got stuck with a non-boston scientific microcatheter after crossing the hub and was not able to remove.As a result, the entire catheter assembly was removed.The procedure was completed with another interlock coil.There were no patient complications as a result of this event.However, device analysis revealed the pusher wire was detached from the heat shrink tfe tubing section.
Additional Manufacturer Narrative
Device analysis findings: upon receipt at our post market quality assurance laboratory, it was observed that the main coil, the introducer sheath and the pusher wire were returned.During visual and microscopic inspections, it was observed that the heat shrink tfe tubing section of the pusher wire and the main coil were stuck inside the introducer sheath.Moreover, the pusher wire was detached from the heat shrink tfe tubing section and the main coil was stretched.During the destructive test, several small cuts were performed to remove the main coil and pusher wire from the introducer sheath however; removal of the main coil was not achieved.Device history record: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50867334
• Report Number: 2124215-2026-50619
• Device Sequence Number: 13434554
• Product Code: KRD
• UDI-Device Identifier: 08714729845287
• UDI-Public: (01)08714729845287(17)251219(10)30881585
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 12/19/2025
• Device Model Number: M001361920
• Device Catalogue Number: M001361920
• Device Lot Number: 0030881585
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• 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 - 2.7F Progreat.
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 145 LB