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

Model Number	24706
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the contralateral approach.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified left superficial femoral artery.After a 6f non-boston scientific (bsc) guide catheter and a non-bsc guide wire crossed the lesion, pre-dilation was performed with a 3x200 non-bsc balloon catheter and was replaced with a 4.0mm x 220mm x 150cm coyote balloon catheter for size up.However, during the second inflation at 14 atmospheres for 120 seconds, the balloon ruptured.The device was removed from the patient without problem and pinhole on the tip side of the balloon was noted.The procedure was completed with a different device.No patient complications were reported and the patient status was good.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13007909
• Report Number: 2134265-2021-15799
• Device Sequence Number: 16585832
• Product Code: DQY
• UDI-Device Identifier: 08714729796671
• UDI-Public: 08714729796671
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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: 05/20/2024
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0027355632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER (ELITECROSS); GUIDEWIRE (CRUISE, AGURUS, GT, VASALLO); INFLATION DEVICE (MERIT); INTRODUCER SHEATH (CROSSROAD 6FR); MICRO CATHETER (PROMANENT)
• Patient Sex: Unknown