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

Model Number	H74939186401210
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation failure occurred.The 100% stenosed target lesion was located in the non-tortuous and heavily calcified superficial femoral artery.A 4.0mm x 120mm x 150cm, coyote balloon catheter was advanced for dilatation.However, after the initial inflation at nominal pressure for 30 seconds, the balloon could not be deflated.The physician ruptured the balloon, and the device was withdrawn from the vessel by pulling back into the catheter and removing both items together.The procedure was completed with another of same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.
Event or Problem Description
It was reported that balloon deflation failure occurred.The 100% stenosed target lesion was located in the non-tortuous and heavily calcified superficial femoral artery.A 4.0mm x 120mm x 150cm, coyote balloon catheter was advanced for dilatation.However, after the initial inflation at nominal pressure for 30 seconds, the balloon could not be deflated.The physician ruptured the balloon, and the device was withdrawn from the vessel by pulling back into the catheter and removing both items together.The procedure was completed with another of same device.There were no patient complications nor injuries reported.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17882180
• Report Number: 2124215-2023-51485
• Device Sequence Number: 7456468
• Product Code: DQY
• UDI-Device Identifier: 08714729797371
• UDI-Public: (01)08714729797371(17)260529(10)31714385
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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: 05/29/2026
• Device Model Number: H74939186401210
• Device Catalogue Number: 24705
• Device Lot Number: 0031714385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• 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
• Patient Sex: Unknown