MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24704
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance clinical study.It was reported that vessel dissection and recoil occurred.The subject underwent treatment with the ranger drug-coated balloon on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was in the right distal popliteal artery, right anterior tibial artery (ata), peroneal artery, right tibial trunk with 6.00 mm proximal reference vessel diameter and 6.00 mm distal reference vessel diameter with lesion length 40 mm with 80% stenosis and was classified as tasc ii a lesion.Prior to target lesion treatment, atherectomy was performed using a 6f 140-sv non-boston scientific (bsc) atherectomy system with cutter catheter device.The treatment of target lesion was performed by dilatation with 4 mm x 60 mm ranger drug-coated balloon.Post treatment, the final residual stenosis was noted to be 0%.On the same day, angiography revealed occlusion in the right proximal ata which was treated by balloon angioplasty with 3 mm x 100 mm coyote balloon catheter that had led to dissection and recoil.As a response to the event, balloon dilations were performed using 3 mm x 100 mm coyote otw balloons followed by placement of 3 mm x 38 mm and 3.50 mm x 32 mm synergy drug eluting stent from ostium to proximal segment of ata in overlapping manner.Post treatment final residual stenosis was noted to be 0 % with relatively good flow distally into the foot.On the following day, the subject was discharged on aspirin.
Additional Manufacturer Narrative
Patient identifier: (b)(6).

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15839162
• Report Number: 2124215-2022-45104
• Device Sequence Number: 6902249
• Product Code: DQY
• UDI-Device Identifier: 08714729796565
• UDI-Public: 08714729796565
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2024
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0027687870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• 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: 56 YR
• Patient Sex: Female
• Patient Race: White