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

Model Number	M001363650
Medical Device Problem Codes	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	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).Upon receipt at our post market quality assurance laboratory, visual inspection of the device revealed that the main coil and the delivery wire were returned with a rotating hemostatic valve (rhv).It was observed that the main coil was bent, stretched and detached at the coil arm section, moreover the main coil lost the form.Dimensional inspection of the main coil and delivery wire revealed the components were within specifications.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 15jul2025.The target lesion was located in the splenic artery.A 15mm x 40cm interlock?-35 coil was selected for embolization.During the procedure, a 5 f angiography catheter was used to deliver the coil with heparin saline infusion throughout, continuous flushing, and it was flushed prior to coil introduction.However, it could not continue to advance at the distal end of the catheter, and the problem still occurred after repeated attempts.The coil was withdrawn from the patient's body, and the procedure was successfully completed by replacing it with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed a main coil detachment at the coil arm section.
Additional Manufacturer Narrative
Updated e1: initial reporter zip/post code.E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).Upon receipt at our post market quality assurance laboratory, visual inspection of the device revealed that the main coil and the delivery wire were returned with a rotating hemostatic valve (rhv).It was observed that the main coil was bent, stretched and detached at the coil arm section, moreover the main coil lost the form.Dimensional inspection of the main coil and delivery wire revealed the components were within specifications.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 15jul2025.The target lesion was located in the splenic artery.A 15mm x 40cm interlock?-35 coil was selected for embolization.During the procedure, a 5 f angiography catheter was used to deliver the coil with heparin saline infusion throughout, continuous flushing, and it was flushed prior to coil introduction.However, it could not continue to advance at the distal end of the catheter, and the problem still occurred after repeated attempts.The coil was withdrawn from the patient's body, and the procedure was successfully completed by replacing it with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed a main coil detachment at the coil arm section.

• 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: 22795570
• Report Number: 2124215-2025-55357
• Device Sequence Number: 15655515
• Product Code: KRD
• UDI-Device Identifier: 08714729793144
• UDI-Public: (01)08714729793144(17)270523(10)34094935
• 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): 11/26/2025

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: M001363650
• Device Catalogue Number: M001363650
• Device Lot Number: 0034094935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 11/02/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 11/26/2025
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 69 KG