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); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: used 11/01/2023 as the event date was not reported.
Event or Problem Description
It was reported that the sheath was fractured.A 12mm x 20cm interlock-35 coil was selected for embolization of fundic varices.During the course of the procedure, the physician was passing the coil through the expect 19g needle.When the protective sheath of the coil was attached to the needle and started to advance the coil, there was a lot of resistance felt.The protective sheath was forcefully pulled out of the three-way stopcock, leaving the coil free in the valve.Upon checking, the tip of the protective sheath was completely wrinkled and fractured at the proximal end due to contact with the edge of the needle.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
B3 - date of event: used 11/01/2023 as the event date was not reported.
Event or Problem Description
It was reported that the sheath was fractured.A 12mm x 20cm interlock-35 coil was selected for embolization of fundic varices.During the course of the procedure, the physician was passing the coil through the expect 19g needle.When the protective sheath of the coil was attached to the needle and started to advance the coil, there was a lot of resistance felt.The protective sheath was forcefully pulled out of the three-way stopcock, leaving the coil free in the valve.Upon checking, the tip of the protective sheath was completely wrinkled and fractured at the proximal end due to contact with the edge of the needle.The procedure was completed with a different device.No patient complications were reported.It was further reported that the device was not fractured but flattened or kinked.

• 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: 18331047
• Report Number: 2124215-2023-69830
• Device Sequence Number: 12459436
• Product Code: KRD
• UDI-Device Identifier: 08714729793175
• UDI-Public: 08714729793175
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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: 08/29/2026
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0032323771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• 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: Male