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

Model Number	24705
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a balloon deflation issue occurred.The patient was undergoing peripheral angioplasty in a mildly tortuous vessel below the knee.Vascular access was obtained via the left femoral artery.The 150mm x 3.0mm target lesion was 100% stenosed and moderately calcified.A 3.0mm x 150mm x 150cm coyote balloon catheter was advanced over a non-boston scientific guidewire.The balloon was inflated once to 8 atmospheres for 120 seconds.The contrast ratio was 100%.During deflation, the balloon would not deflate.The physician attempted different techniques to deflate the balloon, without success.The balloon was removed from the patient intact and remained fully inflated.There were no patient complications.The patient was stable post-procedure.
Event or Problem Description
It was reported that a balloon deflation issue occurred.The patient was undergoing peripheral angioplasty in a mildly tortuous vessel below the knee.Vascular access was obtained via the left femoral artery.The 150mm x 3.0mm target lesion was 100% stenosed and moderately calcified.A 3.0mm x 150mm x 150cm coyote balloon catheter was advanced over a non-boston scientific guidewire.The balloon was inflated once to 8 atmospheres for 120 seconds.The contrast ratio was 100%.During deflation, the balloon would not deflate.The physician attempted different techniques to deflate the balloon, without success.The balloon was removed from the patient intact and remained fully inflated.There were no patient complications.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 h6 evaluation method codes & evaluation conclusion codes: updated 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: 17807375
• Report Number: 2124215-2023-47658
• Device Sequence Number: 7183939
• 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): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 09/25/2023
• 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: 98 KG