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

Model Number	24704
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon failure to deflate occurred.The patient underwent an angioplasty where a 2.5mm x 100mm x 90cm coyote balloon catheter was selected for treatment.During the procedure, it was noted that the balloon was unable to deflate after multiple ongoing attempts.The device was removed from the patient with the balloon still inflated and was replaced for a different model to complete the procedure.No complications reported, and patient status was stable.
Event or Problem Description
It was reported that balloon failure to deflate occurred.The patient underwent an angioplasty where a 2.5mm x 100mm x 90cm coyote balloon catheter was selected for treatment.During the procedure, it was noted that the balloon was unable to deflate after multiple ongoing attempts.The device was removed from the patient with the balloon still inflated and was replaced for a different model to complete the procedure.No complications reported, and patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed stretching to the shaft 11cm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that would have contributed to the reported difficulty to deflate.

• 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: 19071053
• Report Number: 2124215-2024-21452
• Device Sequence Number: 17307895
• Product Code: DQY
• UDI-Device Identifier: 08714729796510
• UDI-Public: 08714729796510
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: 07/26/2026
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0032096390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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