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 Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the non tortuous and severely calcified vessel.A 2.5mm x 150mm x 150cm coyote balloon catheter was advanced for dilatation.However, during first inflation at 6 atmospheres, the balloon ruptured.The procedure was completed with a different device.No patient serious injury nor complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the non tortuous and severely calcified vessel.A 2.5mm x 150mm x 150cm coyote balloon catheter was advanced for dilatation.However, during first inflation at 6 atmospheres, the balloon ruptured.The procedure was completed with a different device.No patient serious injury nor complications were reported.It was further reported that the target lesion was located in the posterior tibial artery.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8459970
• Report Number: 2134265-2019-03097
• Device Sequence Number: 3057748
• Product Code: DQY
• UDI-Device Identifier: 08714729796534
• UDI-Public: 08714729796534
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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: 06/24/2021
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0022294860
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/14/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR