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

Model Number	H74939135254010
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vascular Dissection (3160); Thrombosis/Thrombus (4440)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: not provided and estimated based on aware date.
Event or Problem Description
It was reported that a snare was required to remove a detached balloon.A coyote balloon was selected for use.Under local anesthesia, a retrograde puncture was performed of the right common femoral artery (cfa).A 4 fr sheath was inserted and a pigtail catheter was placed in the infrarenal aorta.Injection of a mechanical contrast medium followed by digital subtraction angiography (dsa) was performed to visualize the iliac vessels on the left.Additional contrast medium injected and staged dsa of the left arterial leg circulation revealed high-grade stenosis of the anterior tibial artery, as well as two further downstream smaller stenoses.A non-bsc guidewire was inserted over the stenosis.Subsequently, a coyote es balloon was inserted however, it could not be advanced over the iliac bifurcation.The coyote es balloon was withdrawn but the distal part of the catheter was sheared.The proximal part of the catheter was removed but the distal part remained in the vessel hanging over the iliac bifurcation.An 8 fr sheath was inserted and multiple attempts to retrieve the device were unsuccessful.During an interim control angiography, a dissection of the right external iliac artery was noticed.It was decided to stent the dissection using the cross-over technique.A further attempt was then made to retrieve the catheter which was ultimately successful.A retrograde puncture of the left cfa was performed and a 5 fr sheath was inserted.Subsequently, cross-over probing of the right iliac artery using a 5 fr non-bsc catheter was performed and a non-bsc guidewire was advanced to the true lumen of the right superficial femoral artery (sfa).Subsequent control angiography revealed a short-segment dissection and thrombosis of the external iliac artery.After interdisciplinary discussion of these findings, it was decided to surgically remove the thrombus and repair the dissection at another point in the future.Finally, the cross-over sluice in the left groin was sutured and a sheath irrigation was created.A pressure bandage was applied to over the puncture site in the right groin.Three milligrams of midazolam was administered periprocedurally and the patient vital signs were monitored.There were no further patient complications reported.
Additional Manufacturer Narrative
B3 - date of event: not provided and estimated based on aware date.Device eval by mfr: the device was returned, and technical analysis was completed.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the hypotube is separated 54.7cm from the tip.There are multiple kinks along the hypotube.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that a snare was required to remove a detached balloon.A coyote balloon was selected for use.Under local anesthesia, a retrograde puncture was performed of the right common femoral artery (cfa).A 4 fr sheath was inserted and a pigtail catheter was placed in the infrarenal aorta.Injection of a mechanical contrast medium followed by digital subtraction angiography (dsa) was performed to visualize the iliac vessels on the left.Additional contrast medium injected and staged dsa of the left arterial leg circulation revealed high-grade stenosis of the anterior tibial artery, as well as two further downstream smaller stenoses.A non-bsc guidewire was inserted over the stenosis.Subsequently, a coyote es balloon was inserted however, it could not be advanced over the iliac bifurcation.The coyote es balloon was withdrawn but the distal part of the catheter was sheared.The proximal part of the catheter was removed but the distal part remained in the vessel hanging over the iliac bifurcation.An 8 fr sheath was inserted and multiple attempts to retrieve the device were unsuccessful.During an interim control angiography, a dissection of the right external iliac artery was noticed.It was decided to stent the dissection using the cross-over technique.A further attempt was then made to retrieve the catheter which was ultimately successful.A retrograde puncture of the left cfa was performed and a 5 fr sheath was inserted.Subsequently, cross-over probing of the right iliac artery using a 5 fr non-bsc catheter was performed and a non-bsc guidewire was advanced to the true lumen of the right superficial femoral artery (sfa).Subsequent control angiography revealed a short-segment dissection and thrombosis of the external iliac artery.After interdisciplinary discussion of these findings, it was decided to surgically remove the thrombus and repair the dissection at another point in the future.Finally, the cross-over sluice in the left groin was sutured and a sheath irrigation was created.A pressure bandage was applied to over the puncture site in the right groin.Three milligrams of midazolam was administered periprocedurally and the patient vital signs were monitored.There were no further patient complications reported.

• Brand Name: COYOTE ES
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MA 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20645755
• Report Number: 2124215-2024-68367
• Device Sequence Number: 18010100
• Product Code: LIT
• UDI-Device Identifier: 08714729767220
• UDI-Public: 08714729767220
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093636
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: H74939135254010
• Device Catalogue Number: H74939135254010
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown