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 Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: patient was over 18 years old.
Event or Problem Description
It was reported that balloon rupture occurred.A 3mm x 20mm x 143 cm coyote es balloon catheter was selected for use for a peripheral lower extremity stent procedure in a moderately calcified, moderately tortuous and 90% stenosed lesion in the left leg.During the procedure, the balloon was inflated and ruptured at 1 atmosphere.The device was removed completely, leaving no remaining parts within the patient, and another of the same balloon was used to successfully complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 3mm x 20mm x 143 cm coyote es balloon catheter was selected for use for a peripheral lower extremity stent procedure in a moderately calcified, moderately tortuous and 90% stenosed lesion in the left leg.During the procedure, the balloon was inflated and ruptured at 1 atmosphere.The device was removed completely, leaving no remaining parts within the patient, and another of the same balloon was used to successfully complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
A2: age at time of event: patient was over 18 years old.Device returned and analyzed by manufacturer.Returned product consisted of a coyote es balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.There was a longitudinal tear 11mm long starting at the proximal end of the balloon.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported balloon ruptured.

• 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: 9934432
• Report Number: 2134265-2020-04491
• Device Sequence Number: 2497667
• Product Code: LIT
• UDI-Device Identifier: 08714729767398
• UDI-Public: 08714729767398
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K093636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2020

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: 07/22/2020
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0022412643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/14/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INNOVA SELF EXPANDING STENT 6 X 40 X 130; INNOVA SELF EXPANDING STENT 6 X 40 X 130