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

Model Number	83787
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that coil protrusion from the target vessel and vessel occlusion occurred.The target lesion was located in the abdominal aorta.During the procedure, a 5f catheter sheath was inserted.A non boston scientific guidewire was entered into the upper segment of the abdominal aorta together with a catheter.Aneurysm dilatation on the the lower segment of the abdominal aorta and the left common artery was revealed by angiography.A single curved angiography catheter along with the guidewire was implanted on the left internal iliac artery.A 6mm x 20cm interlock-35 was selected for use to embolize the internal iliac artery.However, when the coil was deployed, it was noted that the coil was released from the interlocking arms and was placed in an unintended location.The guidewire came out directly from the distal end and the coil remained in the internal cavity.The device was removed manually, and the tumor was treated with another of the same device.Angiography showed that vessel occlusion occurred and there were no signs of contrast agent overflow.There were no further complications reported and the patient was stable post procedure.
Event or Problem Description
It was reported that coil protrusion from the target vessel and vessel occlusion occurred.The target lesion was located in the abdominal aorta.During the procedure, a 5f catheter sheath was inserted.A non boston scientific guidewire was entered into the upper segment of the abdominal aorta together with a catheter.Aneurysm dilatation on the the lower segment of the abdominal aorta and the left common artery was revealed by angiography.A single curved angiography catheter along with the guidewire was implanted on the left internal iliac artery.A 6mm x 20cm interlock-35 was selected for use to embolize the internal iliac artery.However, when the coil was deployed, it was noted that the coil was released from the interlocking arms and was placed in an unintended location.The guidewire came out directly from the distal end and the coil remained in the internal cavity.The device was removed manually, and the tumor was treated with another of the same device.Angiography showed that vessel occlusion occurred and there were no signs of contrast agent overflow.There were no further complications reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: only the main coil was returned.Therefore, the functional test could not be performed due only the main coil was returned.It is observed that the main coil was detached, bent and stretched at the coil arm and primary coil section.No other issues were identified during the product analysis.

• 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: 18497050
• Report Number: 2124215-2024-00765
• Device Sequence Number: 15485224
• Product Code: KRD
• UDI-Device Identifier: 08714729793090
• UDI-Public: 08714729793090
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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: 05/04/2025
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0029344005
• 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: 12/28/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 85 KG