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

Model Number	24698
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter city: yatsushiro city, kumamoto pref.Device evaluated by mfr.: device returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 11mm from the tip.No other damage or irregularities noted in the remainder of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent an endovascular therapy.The 100% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 4.0mm x 150mm x 150cm coyote catheter balloon was advanced for dilation.During the procedure, on the first inflation at 6 atmospheres for 1 second, the balloon ruptured.The device was removed without any problem where it was noted that the rupture was the shape of a pinhole.The procedure was completed using a different device.No complications reported, and patient status was good.
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent an endovascular therapy.The 100% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 4.0mm x 150mm x 150cm coyote catheter balloon was advanced for dilation.During the procedure, on the first inflation at 6 atmospheres for 1 second, the balloon ruptured.The device was removed without any problem where it was noted that the rupture was the shape of a pinhole.The procedure was completed using a different device.No complications reported, and patient status was good.

• 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: 19319424
• Report Number: 2124215-2024-28556
• Device Sequence Number: 7648741
• Product Code: DQY
• UDI-Device Identifier: 08714729797098
• UDI-Public: 08714729797098
• 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): 05/22/2024

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: 12/13/2025
• Device Model Number: 24698
• Device Catalogue Number: 24698
• Device Lot Number: 0030708524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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