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

Model Number	83786
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).Only the main coil was returned for the analysis.Visual inspection revealed the main coil was stretched, detached and bent at the coil arm section.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed.The functional inspection could not be performed due to only the main coil was returned for the analysis.The dimensional inspection revealed that the outer diameter (od) at the zap tip and primary coil were found to be within specification.
Event or Problem Description
Reportable based on the device analysis completed on (b)(6) 2023.It was reported that the coil was stuck in the catheter.The target lesion was located in the femoral artery.An 12mm x 40cm interlock-35 was selected for use.During the procedure, it was noted that the coil was stuck in the middle of the catheter, the coil could not be pushed out.During the operation, water flushing was applied, but it still could not be relieved.The device was removed together with the catheter.The procedure was completed with another of the same device.There were no complications reported and the patient was stable post procedure.However, device analysis revealed that 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 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: 18326360
• Report Number: 2124215-2023-66847
• Device Sequence Number: 7520822
• 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): 12/14/2023

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: 05/18/2025
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0029429728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2023
• 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: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• 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: CORDIS 5F - CONTRAST CATHETER
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 75 KG