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

Model Number	24701
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained utilizing an ipsilateral antegrade approach.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel below the knee.After the lesion were crossed with a non-bsc guidewire and microcatheter with the support of a non-bsc guide catheter, a 2.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, during first inflation at 8 atmospheres, the balloon ruptured.The procedure was completed with a 3mm coyote es balloon catheter.No patient complications were reported.

• Brand Name: COYOTE ES
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11306754
• Report Number: 2134265-2021-01495
• Device Sequence Number: 3374471
• Product Code: LIT
• UDI-Device Identifier: 08714729767381
• UDI-Public: 08714729767381
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2021

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: 02/23/2022
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0025252115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: ELITECROSS; GUIDEWIRE: JUPITER, AGURU, GT; INTRODUCER SHEATH: PARENT4.5FR; MICRO CATHETER: PROMINENT