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	08/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that deflation issue occurred.Vascular access was obtained via the left femoral artery.The 100% stenosed, 150mmx3.0mm, total occluded target lesion with no significant bend was located in the 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.A 3.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilation.With the used of encore 26 inflation device, the balloon was initially inflated at 8 atmospheres for 120 seconds and contrast media and the contrast ratio in the inflation device was 100%.However, the device would not deflate at all.Furthermore, deep-seating and over-inflation and negative pressure with large syringe the balloon was re-inflated, but the balloon still would not be deflated.Hence, additional intervention was performed, and the device was removed from the patient intact in fully inflated state.No patient complications nor serious injuries were reported, and the patient was stable post-procedure.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).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.
Event or Problem Description
It was reported that deflation issue occurred.Vascular access was obtained via the left femoral artery.The 100% stenosed, 150mmx3.0mm, total occluded target lesion with no significant bend was located in the 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.A two 3.0 mm x 150 150mm x 150cm coyote balloon catheters were advanced for dilation in an unknown order.With the used of encore 26 inflation device, the balloon was initially inflated at 8 atmospheres for 120 seconds and contrast media and the contrast ratio in the inflation device was 100%.However, the device would not deflate at all.Furthermore, deep-seating and over-inflation and negative pressure with large syringe the balloon was re-inflated, but the balloon still would not be deflated.Hence, additional intervention was performed, and the device was removed from the patient intact in fully inflated state.No patient complications nor serious injuries 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.

• 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: 17813896
• Report Number: 2124215-2023-47610
• Device Sequence Number: 12574981
• 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: 08/07/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 78 KG