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

Model Number	83779
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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
• 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: 18952143
• Report Number: 2124215-2024-16539
• Device Sequence Number: 15485303
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: 08714729765004
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• 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,Followup
• Report Date (Section B): 05/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2026
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0031778553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: RENEGADE STC-18; MICROCATHETER: RENEGADE STC-18
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female