MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK?-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	M001363590
Medical Device Problem Codes	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	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.Investigation results: device evaluated by mfr: the 2d 8mm x 40cm.035 interlock device was returned to our post market quality assurance laboratory.It was observed that the main coil, the introducer sheath and the delivery wire were returned.It was observed that the main coil was bent and stretched at the primary coil section, moreover the arm coil was detached.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.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.This as analyzed cause was selected since during product analysis it was found the main coil was bent and stretched at the primary coil section, moreover the arm coil was detached, since the pushing force of the user and this opposing force caused by friction are not parallel to each other, as it is related to excessive manipulation of the device and the technique used by the physician during the procedure, the main coil could be affected and consequently collapse forming the damage, this could possibly have affected the performance and integrity of the device.Moreover, a device history record (dhr) review was conducted and no deviations that could have contributed to the reported event were found.Therefore, this investigation is assigned a conclusion code of "adverse event related to procedure" which indicates that the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that device unable to advance occurred.The target lesion was located in the mild tortuous and mild calcified subclaviane.A 2d 8mm x 40cm.035 interlock was selected for use.During the procedure, it was noted that the coil got stuck in the catheter distal part.The procedure was completed with a different device.There were no patient complications as a result of this event.However, returned device analysis revealed a main coil detached.

• Brand Name: INTERLOCK?-35
• 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 ; 9529306396
• MDR Report Key: 25492296
• Report Number: 2124215-2026-31657
• Device Sequence Number: 9734740
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: (01)08714729793014(17)281127(10)38067688
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133208
• 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): 06/12/2026

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 Model Number: M001363590
• Device Catalogue Number: M001363590
• Device Lot Number: 0038067688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2025
• 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 Sex: Male