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

Model Number	83779
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vasoconstriction (2126); Thrombosis/Thrombus (4440)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that a snare was used to retrieve a device fragment.The target lesion was located in the lower limb anterior artery aneurysm.The microcatheter was advanced and reach the main trunk, the heparin saline was manually injected, and the 8mm x 20cm 2d interlock coil was advanced and released smoothly.Upon removing the delivery wire, it was found that there was a small band wire in the microcatheter under the transmission.The length was from the opening of the anterior radial artery to the middle segment of the superficial femoral artery.The physician withdrew the microcatheter by using a snare to catch the band wire and pulled it out from the patient.Because of the operation time took too long, spasms and thrombosis occurred in the popliteal artery.Because of the repeated attempts to pull the coil out with the snare, the catheter irritates the lining of the blood vessel causing spasm and thrombosis.The thrombus was extracted by a 6f guide catheter with a syringe.The patient was given urokinase and papaverine, and the blood flow in the popliteal artery was recovered.The anterior radial artery has no blood flow, and the aneurysm was not visible on imaging.The procedure was completed with no further complications.The patient condition following procedure was stable.
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Visual and microscopic inspection observed that only the main coil was returned, and it was bent and stretched at the coil arm and primary coil section.Moreover, the arm coil was detached.Functional inspection could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection was performed, and the main coil's max zap tip outer diameter (od) and primary coil od passed the specification test.
Event or Problem Description
It was reported that a snare was used to retrieve a device fragment.The target lesion was located in the lower limb anterior artery aneurysm.The microcatheter was advanced and reach the main trunk, the heparin saline was manually injected, and the 8mm x 20cm 2d interlock coil was advanced and released smoothly.Upon removing the delivery wire, it was found that there was a small band wire in the microcatheter under the transmission.The length was from the opening of the anterior radial artery to the middle segment of the superficial femoral artery.The physician withdrew the microcatheter by using a snare to catch the band wire and pulled it out from the patient.Because of the operation time took too long, spasms and thrombosis occurred in the popliteal artery.Because of the repeated attempts to pull the coil out with the snare, the catheter irritates the lining of the blood vessel causing spasm and thrombosis.The thrombus was extracted by a 6f guide catheter with a syringe.The patient was given urokinase and papaverine, and the blood flow in the popliteal artery was recovered.The anterior radial artery has no blood flow, and the aneurysm was not visible on imaging.The procedure was completed with no further complications.The patient condition following 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: 20128316
• Report Number: 2124215-2024-53956
• Device Sequence Number: 20682283
• Product Code: KRD
• UDI-Device Identifier: 08714729765011
• UDI-Public: 08714729765011
• 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): 11/04/2024

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 Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0033138142
• 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: 08/09/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 51 KG