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 Consequences Or Impact To Patient (2199)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the tibial artery.A 2.0mm x 100mm x 150cm coyote and a 2mm x 40mm x 144cm coyote es balloon catheters were used consecutively for dilatation.However, during first inflations, the balloons ruptured.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Device evaluated by mfr.: returned product consisted of a coyote balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was blood and contrast in the inflation lumen and balloon.Microscopic inspection revealed a longitudinal tear 19mm long starting 41mm distal from the proximal marker band and tip damage.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the tibial artery.A 2.0mm x 100mm x 150cm coyote and a 2mm x 40mm x 144cm coyote es balloon catheters were used consecutively for dilatation.However, during first inflations, the balloons ruptured.The procedure was completed with a different device.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: 8695194
• Report Number: 2134265-2019-06193
• Device Sequence Number: 1888913
• Product Code: DQY
• UDI-Device Identifier: 08714729797135
• UDI-Public: 08714729797135
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K111295
• 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): 07/10/2019

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: 04/28/2022
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0023708286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1