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

Model Number 24691

Device Problems Entrapment of Device (1212); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that catheter entrapment occurred.The 100% stenosed target lesion was located in the mildly calcified superficial femoral artery (sfa).In-stent restenosis was noted.A guidewire crossed the lesion inside the previously placed 7x40,130cm eluvia drug-eluting vascular stent system.A coyote balloon was delivered.The lesion was dilated and the guidewire remained in place.During removal of the balloon, the shaft near the wire exit port became kinked.The guidewire and the balloon were removed together from the patient.The procedure was completed with a different device.There were no further patient complications reported.

Event Description

It was reported that catheter entrapment occurred.The 100% stenosed target lesion was located in the mildly calcified superficial femoral artery (sfa).In-stent restenosis was noted.A guidewire crossed the lesion inside the previously placed 7x40,130cm eluvia drug-eluting vascular stent system.A coyote balloon was delivered.The lesion was dilated and the guidewire remained in place.During removal of the balloon, the shaft near the wire exit port became kinked.The guidewire and the balloon were removed together from the patient.The procedure was completed with a different device.There were no further patient complications reported.

Manufacturer Narrative

(e1) initial reporter city: (b)(6).Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.A non-boston scientific guidewire was stuck in the device.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.There was a tear at the exit notch extending 19mm distally.The inner shaft was stretched down for 2mm starting 47mm from the tip.The balloon was buckled.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: COYOTE ES
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10033165
• MDR Text Key: 190676573
• Report Number: 2134265-2020-06175
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767176
• UDI-Public: 08714729767176
• Combination Product (y/n): N
• PMA/PMN Number: K093636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0024853775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: JUPITERX 235CM; GUIDEWIRE: JUPITERX 235CM; INFLATION DEVICE: GOODMAN; INFLATION DEVICE: GOODMAN; INTRODUCER SHEATH: PARETN 60 43CM; INTRODUCER SHEATH: PARETN 60 43CM