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

Model Number	24696
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2020
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 contralateral approach.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.After a guidewire crossed the lesion, a 4.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with a non-bsc balloon catheter.There were no patient complications reported.

• 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: 10144808
• Report Number: 2134265-2020-07862
• Device Sequence Number: 11526514
• Product Code: LIT
• UDI-Device Identifier: 08714729797067
• UDI-Public: 08714729797067
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

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: 11/13/2021
• Device Model Number: 24696
• Device Catalogue Number: 24696
• Device Lot Number: 0022937286
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2020
• Initial Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1