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

Model Number 83786

Device Problems Premature Activation (1484); Failure to Advance (2524); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3 - date of event: used 11/01/2023 as the event date was not reported.

Event 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.

Manufacturer Narrative

B3 - date of event: used 11/01/2023 as the event date was not reported.

Event 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
• Type of Device: 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
• MDR Text Key: 330577314
• Report Number: 2124215-2023-69830
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793175
• UDI-Public: 08714729793175
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K133208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male