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

Model Number	M001363820
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Stretched (1601); 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	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil protruded from the catheter's tip during withdrawal from the patient.The target lesion was located in the internal iliac artery.A 15mm x 40cm interlock.035 coil was selected for transcatheter internal iliac artery embolization.However, after the coil was pushed out of the 5f non-boston scientific catheter for about 5 cm, it was noted that the part within the catheter could not be pushed out or pulled back.The physician could only withdraw the coil and the protective sheath together from the patient's body.Attempting to push or pull the coil outside the patient's body also resulted in the same outcome.After taking out the coil, it was found that the coil was stretched.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).Good faith effort attempts were made to retrieve additional details regarding the device status, but further information was unable to be obtained.
Additional Manufacturer Narrative
(b)(6).Investigation results: device evaluated by mfr: the interlock.035 device was returned to our post market quality assurance laboratory.A visual and microscopic inspection was performed and identified that the main coil was deformed at the primary coil section, moreover the zap tip was detached.Dimensional inspection of the main coil revealed the components were within specifications.This concludes the product analysis.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.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the interlock.035 device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event.
Event or Problem Description
It was reported that the coil protruded from the catheter's tip.The target lesion was located in the internal iliac artery.A 15mm x 40cm interlock.035 coil was selected for transcatheter internal iliac artery embolization.However, after the coil was pushed out of the catheter for about 5 cm, it was noted that the part within the catheter could not be pushed out or pulled back.The physician could only withdraw the coil and the protective sheath together from the patient's body.Attempting to push or pull the coil outside the patient's body also resulted in the same outcome.After taking out the coil, it was found that the coil was stretched.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.

• 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: 23854873
• Report Number: 2124215-2025-92062
• Device Sequence Number: 4989730
• Product Code: KRD
• UDI-Device Identifier: 08714729795438
• UDI-Public: (01)08714729795438(17)271111(10)35254635
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 04/09/2026

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: M001363820
• Device Catalogue Number: M001363820
• Device Lot Number: 0035254635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER: 5F CORDIS CATHETER; CATHETER: 5F CORDIS CATHETER
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 70 KG