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

Model Number	24704
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred and the procedure was cancelled.The 70% stenosed target lesion was located in the severely tortuous and severely calcified dorsalis pedis artery.A 1.5mm x 40mm x 150cm, coyote balloon catheter was advanced for dilation.However, during the second inflation at 14 atmospheres for 10 minutes, the balloon ruptured.The procedure was not completed due to this event.There were no patient complications nor injuries reported and the patient's status was good.
Additional Manufacturer Narrative
D4: lot number updated from 0027754528 to 0027592570.D4: expiration date updated from 07/29/2024 to 06/30/2024.H4: device manufacture date updated from 07/30/2021 to 07/01/2021.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.Visual and microscopic examination revealed no damages.The balloon was inflated to rated burst pressure and was able to hold pressure.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred and the procedure was cancelled.The 70% stenosed target lesion was located in the severely tortuous and severely calcified dorsalis pedis artery.A 1.5mm x 40mm x 150cm,coyote balloon catheter was advanced for dilation.However, during the second inflation at 14 atmospheres for 10 minutes, the balloon ruptured.The procedure was not completed due to this event.There were no patient complications nor injuries reported and the patient's status 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13472509
• Report Number: 2134265-2022-00593
• Device Sequence Number: 14670165
• Product Code: DQY
• UDI-Device Identifier: 08714729796411
• UDI-Public: 08714729796411
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 03/23/2022

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: 06/30/2024
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0027592570
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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
• Patient Age: 70 YR
• Patient Sex: Male