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

Model Number 83779

Device Problems Premature Activation (1484); Failure to Advance (2524); Positioning Problem (3009)

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

Event Date 03/01/2024

Event Type  Injury  

Event Description

It was reported that the coil was removed with a snare.The target lesion was located in the severely tortuous inferior mesenteric artery.After placing a renegade stc-18 microcatheter, a 6mm x 20cm interlock was selected for use.However, during the procedure, the coil was not pushed smoothly, and the catheter popped out after the obstruction resulting in the detachment of the coil inside the patient.The coil was removed with a snare.A 35-system, 8mm x 40cm interlock with a 5f non-boston scientific angiographic catheter were selected for embolization and reduction.The angiography was normal, and the procedure was completed successfully.There were no complications reported and the patient was stable post procedure.

Event Description

It was reported that the coil was removed with a snare.The target lesion was located in the severely tortuous inferior mesenteric artery.After placing a renegade stc-18 microcatheter, a 6mm x 20cm interlock was selected for use.However, during the procedure, the coil was not pushed smoothly, and the catheter popped out after the obstruction resulting in the detachment of the coil inside the patient.The coil was removed with a snare.A 35-system, 8mm x 40cm interlock with a 5f non-boston scientific angiographic catheter were selected for embolization and reduction.The angiography was normal, and the procedure was completed successfully.There were no complications reported and the patient was stable post procedure.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the main coil, introducer sheath and the pusher wire were returned.It was observed that the main coil was bent and stretched at all primary coil section.The functional inspection could not be performed due the main coil and the pusher wire are not interlocking.

• Brand Name: INTERLOCK
• 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: 18952143
• MDR Text Key: 338302411
• Report Number: 2124215-2024-16539
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: 08714729765004
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0031778553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• 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
• Treatment: MICROCATHETER: RENEGADE STC-18; MICROCATHETER: RENEGADE STC-18
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female