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

Model Number	24705
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion containing 90 degrees bend was located in the mildly tortuous and severely calcified posterior tibial artery.A 2.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilatation around the bend.The balloon was initially inflated at 14 atmospheres for 3 minutes.However, during the second inflation at 12 atmospheres, the balloon ruptured and the device was removed normally over a 300cm angled tip v-14 control wire.While attempting to extract the balloon and the wire for angiogram, it was found that the wire tip was fractured and stuck at the junction of the plantar arteries in the posterior tibial artery.Approximately two hours was spent in attempting to extract the wire fragment using a 3.2 fr non-boston scientific snare.Finally, the wire fragment was retracted to the distal superficial femoral artery level.However, the wire tip embolized into the dorsalis pedis and access into the dorsalis pedis was gained.A non- boston scientific aspiration catheter was used and was able to aspirate the wire fragment.The left lower extremity was imaged in its entirety without evidence of residual fragment.The procedure was completed a different device.No patient complications were reported and the patient was doing well post procedure.It was further reported that before the guide wire failure occurred, there was resistance during advancing and removing of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion containing 90 degrees bend was located in the mildly tortuous and severely calcified posterior tibial artery.A 2.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilatation around the bend.The balloon was initially inflated at 14 atmospheres for 3 minutes.However, during the second inflation at 12 atmospheres, the balloon ruptured and the device was removed normally over a 300cm angled tip v-14 control wire.While attempting to extract the balloon and the wire for angiogram, it was found that the wire tip was fractured and stuck at the junction of the plantar arteries in the posterior tibial artery.Approximately two hours was spent in attempting to extract the wire fragment using a 3.2 fr non-boston scietific snare.Finally, the wire fragment was retracted to the distal superficial femoral artery level.However, the wire tip embolized into the dorsalis pedis and access into the dorsalis pedis was gained.A non- boston scientific aspiration catheter was used and was able to aspirate the wire fragment.The left lower extremity was imaged in its entirety without evidence of residual fragment.The procedure was completed a different device.No patient complications were reported and the patient was doing well post procedure.It was further reported that before the guide wire failure occurred, there was resistance during advancing and removing of the device.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a coyote balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed buckling 5mm, 7mm, 9mm, and 14mm from the tip.Microscopic examination revealed damage to the tip.There is a tear to the guidewire lumen from the tip to 4mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a tear on the tip.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12375711
• Report Number: 2134265-2021-10621
• Device Sequence Number: 19818161
• Product Code: DQY
• UDI-Device Identifier: 08714729796459
• UDI-Public: 08714729796459
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/19/2024
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0027347949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 09/27/2021
• Patient Sequence Number: 1
• Patient Age: 64 YR