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

Model Number	H74939186252210
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon was unable to deflate.The target lesion was located in the anterior tibial artery below the knee.A 2.5mm x 220mm x 150cm coyote was advanced for dilation.During the procedure, it was noted that the balloon was unable to deflate.The balloon was simply pulled out carefully and slowly and the procedure was completed with another of the same device.No complications were reported, and patient was stable post-procedure.
Additional Manufacturer Narrative
El - initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The device was inflated to rated burst pressure and then deflated without any issues.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the failure to deflate.
Event or Problem Description
It was reported that the balloon was unable to deflate.The target lesion was located in the anterior tibial artery below the knee.A 2.5mm x 220mm x 150cm coyote was advanced for dilation.During the procedure, it was noted that the balloon was unable to deflate.The balloon was simply pulled out carefully and slowly and the procedure was completed with another of the same device.No complications were reported, and patient was stable post-procedure.
Event or Problem Description
It was reported that the balloon was unable to deflate.The target lesion was located in the anterior tibial artery below the knee.A 2.5mm x 220mm x 150cm coyote was advanced for dilation.During the procedure, it was noted that the balloon was unable to deflate.The balloon was simply pulled out carefully and slowly and the procedure was completed with another of the same device.No complications were reported, and patient was stable post-procedure.
Additional Manufacturer Narrative
El - initial reporter address 1: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The device was inflated to rated burst pressure and then deflated without any issues.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the failure to deflate.This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.

• 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: 18278932
• Report Number: 2124215-2023-66216
• Device Sequence Number: 6189809
• Product Code: DQY
• UDI-Device Identifier: 08714729796718
• UDI-Public: (01)08714729796718(17)251004(10)30287120
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2024

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: 10/04/2025
• Device Model Number: H74939186252210
• Device Catalogue Number: 24706
• Device Lot Number: 0030287120
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 12/14/2023; 06/12/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/02/2024; 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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