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	04/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified right superficial femoral artery.A 4.0mmx220mmx150cm coyote balloon catheter and a 4.00mm/1.5cm/140cm small peripheral cutting balloon were used together.After positioning the sheath, the lesion was crossed with the support catheter, micro catheter, and guidewire.Dilation was performed using coyote balloon, however it ruptured in a pinhole form slightly near the tip from the center upon second inflation at 14atm for 30seconds.Subsequently, pcb was used for dilation of the residual stenosis but it also ruptured upon second inflation at 10atm.The same lesion was dilated using a pcb of the same size, and the procedure was completed by performing post with oceanus 4-200.There were no patient complications reported.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14252002
• Report Number: 2134265-2022-04618
• Device Sequence Number: 4887069
• 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): 04/29/2022

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: 11/08/2024
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0028353531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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: BALLOON CATHETER- OCEANUS; GUIDE CATHETER - ELITE CROSS; GUIDEWIRE - CRUISE, AGURUS, VASSALLO; INFLATION DEVICE - MERIT; INTRODUCER SHEATH - 6FR CROSSROAD; MICRO CATHETER - PROMANENT
• Patient Sex: Unknown