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

Model Number	M001363580
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 10apr2025.It was reported that the coil would not advance out in the catheter.The target lesion was located in the splenic artery.An 8mm x 20cm interlock-35 was selected for use.However, during the procedure, it was noted that the coil stopped at the tip of the catheter and would not advance out.When attempting to withdraw, the coil 'unwound' and had to pull the entire catheter and coil together.There were no patient complications as a result of this event.However, device analysis revealed the arm coil was detached.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned to our post market quality assurance laboratory.Visual and microscopic inspections were performed, and it was observed that the main coil and the delivery wire were returned with a non-boston scientific (bsc) catheter.The delivery wire returned stuck inside the non-bsc catheter.It was observed that the main coil was bent and stretched at the coil arm and primary coil section.Moreover, the arm coil was detached.The delivery wire was damaged at the wire arm section.Dimensional inspection of the main coil and delivery wire revealed the components were within specifications.No other issues were identified during the product analysis.

• 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: 21962501
• Report Number: 2124215-2025-26793
• Device Sequence Number: 18441022
• Product Code: KRD
• UDI-Device Identifier: 08714729793045
• UDI-Public: (01)08714729793045(17)260522(10)31673655
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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 Expiration Date: 05/22/2026
• Device Model Number: M001363580
• Device Catalogue Number: M001363580
• Device Lot Number: 0031673655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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: Unknown