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

Model Number	83786
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Only the main coil was returned for the analysis.Under visual and microscope inspection revealed that the main coil was stretched bend and detached at the coil arm section.No more damage was observed.The functional test could not be performed due only the main coil was returned.Dimensional inspection on zap tip od (outer diameter), primary coil od and coil arm od (max) revealed within specification.
Event or Problem Description
Reportable based on device analysis completed on 21aug2023.It was reported that the coil stuck halfway and could not be pushed out.The 50% stenosed target lesion was located in the mildly tortuous and moderately calcified common iliac artery.A 10mm x 20cm interlock-35 coil was selected for use.During the procedure, after many attempts of adjusting, the coil could not advance and was stuck halfway through the microcatheter and could not be pushed out.The device was simply pulled out from the patient's body.The procedure was completed with another of same device.There were three coils used in total.No complications were reported, and patient was stable post procedure.However, device analysis confirmed that the main coil detached 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17732582
• Report Number: 2124215-2023-46734
• Device Sequence Number: 6440476
• Product Code: KRD
• UDI-Device Identifier: 08714729793137
• UDI-Public: 08714729793137
• 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): 09/12/2023

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: 05/11/2025
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0029386268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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: 2.6F TERUMO CATHETER
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 75 KG