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

Model Number	M001363580
Medical Device Problem Codes	Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: device eval by manufacturer: upon receipt at our post market quality assurance laboratory, the 8mm x 20cm interlock.035 was visually and microscopically examined.The main coil was returned and found to be bent and stretched at the primary coil section, and the arm coil was found detached.Device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event investigation conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was adverse event related to procedure.
Event or Problem Description
Reportable based on the device analysis completed on (b)(6) 2026.It was reported that the coil was stretched.The target lesion was located in the hypogastric aneurysm.A 8mm x 20cm interlock.035 was selected for use.During the procedure, the coil was being deployed and repositioned when the physician experienced stretching of the coil.The device had not exhibited any issues upon opening and was used for the first time.During the attempt to reposition, the coil elongated, and removal was deemed the only viable option.The coil was successfully withdrawn from the patient by pulling it out along with the diagnostic catheter.The procedure was then completed there were no patient complications as a result of this event.However, returned device analysis revealed main coil detachment.

• 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: 25127982
• Report Number: 2124215-2026-25110
• Device Sequence Number: 8634677
• Product Code: KRD
• UDI-Device Identifier: 08714729793045
• UDI-Public: (01)08714729793045(17)270523(10)34094928
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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: M001363580
• Device Catalogue Number: M001363580
• Device Lot Number: 0034094928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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: 71 YR
• Patient Sex: Male