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

Model Number	24705
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the right femoral artery.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified right anterior tibial artery.After a 6f non-boston scientific (bsc) guide catheter was inserted and a non-bsc guidewire crossed the lesion, a 3.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilation.However, during the first inflation at 10 atmospheres for 10 seconds, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient condition was good.
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).Device evaluated by mfr.: returned product consisted of a coyote balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.The batch # was confirmed correct.The device showed signs of use.Microscopic investigation revealed a hole in the balloon 4.8 cm from the distal tip of the balloon.A kink was measured 72.2 cm from the hub, and another was 4.8 cm from the distal tip under the balloon.No other damage was seen.Device analysis determined the condition of the returned device was consistent with the reported information of a material rupture.Because there was no evidence of any product quality deficiencies, it was considered likely that the kinks were attributable to procedural issues therefore, the conclusion code adverse event related to procedure caused or contributed to the event.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the right femoral artery.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified right anterior tibial artery.After a 6f non-boston scientific (bsc) guide catheter was inserted and a non-bsc guidewire crossed the lesion, a 3.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilation.However, during the first inflation at 10 atmospheres for 10 seconds, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient condition was good.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14518065
• Report Number: 2134265-2022-06073
• Device Sequence Number: 12369385
• Product Code: DQY
• UDI-Device Identifier: 08714729796589
• UDI-Public: 08714729796589
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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: 06/20/2024
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0027526914
• 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: 05/23/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• 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: GUIDEWIRE: VASALLO FLOPPY; GUIDEWIRE: VASALLO FLOPPY; INFLATION DEVICE: ENCORE; INFLATION DEVICE: ENCORE; INTRODUCER SHEATH: 6F DESTINATION; INTRODUCER SHEATH: 6F DESTINATION; MICRO CATHETER: PROMINENT; MICRO CATHETER: PROMINENT
• Patient Sex: Unknown