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

Model Number	83786
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Only the main coil and the pouch were returned for the analysis.Visual inspection revealed the main coil was stretched, detached and bent at the coil arm section.No more damages were observed.The functional inspection could not be performed due only the main coil being returned for the analysis.Dimensional inspection revealed that the zap tip od (outer diameter) and primary coil od were within specification.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023.It was reported that the coil could not advance out of the imaging catheter.The target lesion was located in the abdominal aorta.A 12mm x 40cm interlock-35 coil was selected for use.The imaging catheter was connected with high pressure saline and was flushed intermittently before introduction of the coil.During the procedure, it was noted that the coil could not advance out of the 5f cordis catheter.When advance for the second time, it got detached inside the catheter.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18268888
• Report Number: 2124215-2023-66439
• Device Sequence Number: 14454727
• Product Code: KRD
• UDI-Device Identifier: 08714729792970
• UDI-Public: 08714729792970
• 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): 12/05/2023

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: 10/25/2025
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0030422048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• 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: IMAGING CATHETER - 5F CORDIS CATHETER.
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 60 KG