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

Model Number	24706
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that shaft break and balloon detachment occurred.A 2.0mm x 220mm x 150cm, otw coyote balloon dilatation catheter was advanced.However, during the procedure, the balloon broke, and kinks were also noted in the multiple areas of the device.No patient harm resulted in relation to this event.
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr: returned product consisted of a coyote balloon catheter.Media was provided in the form of 6 photos.The returned device was compared to the photos, and it appears to match.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the device returned in 4 pieces.The distal section of the device measures approximately 34.9cm long with the tip missing.The inflation lumen and guidewire lumen are buckled at the separated tip.The separated guidewire lumen measures approximately 41cm long and is stretched.The separated inflation lumen measures approximately 5.7cm long and is buckled.The proximal section of the device measures approximately 107.9cm long from the hub to the separated guidewire lumen.The are multiple kinks along the shaft of the device.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed that the device is separated and severely damaged.
Event or Problem Description
It was reported that shaft break and balloon detachment occurred.A 2.0mm x 220mm x 150cm, otw coyote balloon dilatation catheter was advanced.However, during the procedure, the balloon broke, and kinks were also noted in the multiple areas of the device.No patient harm resulted in relation to this event.

• 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: 17666555
• Report Number: 2124215-2023-43436
• Device Sequence Number: 7087749
• Product Code: DQY
• UDI-Device Identifier: 08714729796466
• UDI-Public: 08714729796466
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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: 05/11/2026
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0031604510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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
• Patient Sex: Unknown