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

Model Number	M001361950
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the coil was protruding from the catheter's tip upon removal.A 2d 20mm x 50cm interlock coil was selected for abdominal aortic aneurysm endovascular isolation procedure.During the procedure, a non-boston scientific (bsc) microcatheter was used to deliver the coil into the right iliac artery, and the catheter was continuously flushed with pressurized heparin saline using a y valve.However, the coil became stuck in the microcatheter, and half of the coil was in the tumor body.The coil was then removed together with the microcatheter from the patient's body; however, it was noted that the coil was protruding from the catheter's tip upon removal.The procedure was completed with another of the same device.The patient's condition following the procedure was stable.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the device was returned for evaluation.Visual and microscopic inspections were performed, and it was observed that the main coil, the introducer sheath and the pusher wire were returned.It was observed that the main coil was bent and stretched at the primary coil and arm coil section.The functional could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection of the main coil revealed the components were within specifications.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the coil was protruding from the catheter's tip upon removal.A 2d 20mm x 50cm interlock coil was selected for abdominal aortic aneurysm endovascular isolation procedure.During the procedure, a non-boston scientific (bsc) microcatheter was used to deliver the coil into the right iliac artery, and the catheter was continuously flushed with pressurized heparin saline using a y valve.However, the coil became stuck in the microcatheter, and half of the coil was in the tumor body.The coil was then removed together with the microcatheter from the patient's body; however, it was noted that the coil was protruding from the catheter's tip upon removal.The procedure was completed with another of the same device.The patient's condition following the procedure was stable.

• 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: 20847156
• Report Number: 2124215-2024-75281
• Device Sequence Number: 11702183
• Product Code: KRD
• UDI-Device Identifier: 08714729845317
• UDI-Public: 08714729845317
• 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): 01/16/2025

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 Model Number: M001361950
• Device Catalogue Number: M001361950
• Device Lot Number: 0033948949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 12/25/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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 - TERUMO; MICROCATHETER - TERUMO
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 60 KG