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

Model Number 24698

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  malfunction  

Event Description

It was reported that the balloon ruptured.A coyote, 3.0mm x 150mm x 150cm was selected for use in a percutaneous transluminal angioplasty procedure, to treat peripheral artery disease.The 100% stenosed target lesion was located in the moderately tortuous, severely calcified, superficial femoral artery (sfa).During the procedure, it was noted that the balloon ruptured at 10 atmospheres upon second inflation.The first inflation was for one minute with a pressure at 8 atmospheres and the second inflation was for 5 seconds.A pinhole was observed.The device was removed and the procedure was completed with a different device.There were no complications reported.

• Brand Name: COYOTE
• Type of Device: 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: 13087332
• MDR Text Key: 282779203
• Report Number: 2134265-2021-16196
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729796947
• UDI-Public: 08714729796947
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24698
• Device Catalogue Number: 24698
• Device Lot Number: 0027703733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1