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

Model Number	24698
Medical Device Problem Codes	Deflation Problem (1149); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.
Event or Problem Description
It was reported that the balloon was slow to deflate.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified left vessel below the knee.A 3.0mmx150mmx150cm was advanced for dilation.During the procedure, the balloon was pressurized upon first inflation at 14 atmospheres for 2 minutes.However, during the second inflation at 14 atmospheres, it took 10 minutes for the contrast agent to be removed and for the balloon to deflate.The balloon was removed after it was deflated, and the procedure was completed with another of the same device.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that the balloon was slow to deflate.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified left vessel below the knee.A 3.0mmx150mmx150cm was advanced for dilation.During the procedure, the balloon was pressurized upon first inflation at 14 atmospheres for 2 minutes.However, during the second inflation at 14 atmospheres, it took 10 minutes for the contrast agent to be removed and for the balloon to deflate.The balloon was removed after it was deflated, and the procedure was completed with another of the same device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.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 examination revealed a kink to the shaft 37.5cm from the tip.Microscopic examination revealed no additional damages.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: 18335642
• Report Number: 2124215-2023-69858
• Device Sequence Number: 8425049
• Product Code: LIT
• UDI-Device Identifier: 08714729796947
• UDI-Public: 08714729796947
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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: 06/13/2026
• Device Model Number: 24698
• Device Catalogue Number: 24698
• Device Lot Number: 0031814832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• 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 - GUIDEZILLA; GUIDE CATHETER - GUIDEZILLA; GUIDEWIRE - JUPITERFC3; GUIDEWIRE - JUPITERFC3; INFLATION DEVICE - ASSIST; INFLATION DEVICE - ASSIST; INTRODUCER SHEATH - PARENT5082; INTRODUCER SHEATH - PARENT5082; MICRO CATHETER - RUBICON; MICRO CATHETER - RUBICON
• Patient Sex: Male