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

Model Number	24705
Medical Device Problem Codes	Leak/Splash (1354); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon would not deflate.Vascular access was obtained via the right femoral artery.The 100% stenosed, 140mmx3.0mm, total occluded target lesion was located in a mildly tortuous and moderately calcified vessel below the knee.After a 6f non-boston scientific (bsc) guide catheter was engaged coaxially and a non-bsc guidewire was crossed the lesion.Pre-dilation was performed, then a 3.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilation.Using an encore 26 inflation device, the balloon was initially inflated at 8 atmospheres for 120 seconds.The contrast ratio in the inflation device was 100%.The balloon would not deflate despite multiple attempts and techniques.The balloon tore while pulling and was then able to be removed from the patient intact and fully deflated.No patient complications were reported, and the patient was stable post-procedure.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the balloon would not deflate.Vascular access was obtained via the right femoral artery.The 100% stenosed, 140mmx3.0mm, total occluded target lesion was located in a mildly tortuous and moderately calcified vessel below the knee.After a 6f non-boston scientific (bsc) guide catheter was engaged coaxially and a non-bsc guidewire was crossed the lesion.Pre-dilation was performed, then a 3.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilation.Using an encore 26 inflation device, the balloon was initially inflated at 8 atmospheres for 120 seconds.The contrast ratio in the inflation device was 100%.The balloon would not deflate despite multiple attempts and techniques.The balloon tore while pulling and was then able to be removed from the patient intact and fully deflated.No patient complications were reported, and the patient was stable post-procedure.It was further reported that a 50/50 ratio of contrast to sterile saline was used, not 100% contrast as previously reported.
Additional Manufacturer Narrative
B5: describe event or problem: updated e1 - initial reporter phone: (b)(6).Device/media analysis: the complaint device was not returned for analysis.Photos of the device and video were received.Review of the media received was unable to identify any visible damage.Based on the device not being returned to bsc for investigation and no damage observed in the media provided, the cause of the reported issue could not be established.

• 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: 17675037
• Report Number: 2124215-2023-47661
• Device Sequence Number: 6512638
• Product Code: DQY
• UDI-Device Identifier: 08714729796589
• UDI-Public: 08714729796589
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2026
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0030925503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 09/03/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: COMMOND 0,014, MEDIKIT; GUIDE CATHETER: COMMOND 0,014, MEDIKIT; INFLATION DEVICE: ENCORE 26; INFLATION DEVICE: ENCORE 26
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 75 KG