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

Model Number	M001363660
Medical Device Problem Codes	Separation Failure (2547); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 (b)(6).Device evaluated by mfr.: the device was returned for analysis.Visual and microscopic inspection observed that the main coil, the delivery sheath and the introducer sheath were returned.The main coil was detached, bent and stretched at the primary coil and arm coil section.Moreover, the introducer sheath was bent before the twist lock.Functional inspection could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection was performed, and the main coil's max zap tip outer diameter (od) and primary coil od passed the specification test.Based on the evidence, the reported allegation of main coil failed to separate was confirmed, since the bent and stretched found during the product inspection, could have contributed to the reported issue.
Event or Problem Description
Reportable based on device analysis completed on 25nov2024.It was reported that the coil failed to deploy.The target lesion was located in the abdominal aorta.A 18mm x 20cm interlock-35 coil was advanced for embolization.During the deployment, the interlocking arm could not be opened.The procedure was completed with the same type of device.No complications were reported, and the patient condition following procedure was stable.However, returned device analysis revealed the main coil was detached.

• 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: 20894664
• Report Number: 2124215-2024-77157
• Device Sequence Number: 8710323
• Product Code: KRD
• UDI-Device Identifier: 08714729797432
• UDI-Public: 08714729797432
• 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): 12/10/2024

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: 07/17/2026
• Device Model Number: M001363660
• Device Catalogue Number: M001363660
• Device Lot Number: 0032037351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 68 KG