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

Model Number	M001363590
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reported facility name: (b)(6).The device was returned for analysis.Upon inspection, it was confirmed that the main coil, introducer sheath, and delivery wire were included in the return.Further examination revealed that the main coil exhibited bending and stretching at both the coil arm and primary coil sections.The main coil itself was observed to be detached, bent, and stretched.A photograph included in the parent record allowed for visual confirmation of the bending and stretching of the main coil; however, the specific issue reported (main coil premature deployment inside the patient) is not clearly depicted in the image.Based on the available evidence, the reported issue, "main coil premature deployment inside patient," cannot be conclusively verified.Functional evaluation of the main coil to confirm this type of failure is not possible given the current condition of the device.
Event or Problem Description
Reportable based on the device analysis completed on (b)(6) 2025.It was reported that premature deployment occurred.The stenosed target lesion was located in the internal iliac artery.An 8mmx40cm interlock embolics device was selected for use.During the procedure, the initial 10x40 interlock coil was deployed, but its position was deemed unsatisfactory.An attempt to withdraw the coil was unsuccessful initially, as it could not be retracted as intended.The coil was eventually retrieved from the patients body using the catheter.A second coil of the same model was then successfully deployed.During the deployment of the third 8x40 interlock coil, detachment occurred; however, the coil was successfully withdrawn from the patients body using the catheter.There were no patient complications as a result of this event.However, device analysis revealed that the main coil was detached, bent and stretched.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21890600
• Report Number: 2124215-2025-23268
• Device Sequence Number: 17002698
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: (01)08714729793014(17)270109(10)33179185
• 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
• Report Date (Section B): 04/23/2025

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 Model Number: M001363590
• Device Catalogue Number: M001363590
• Device Lot Number: 0033179185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 71 KG