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

Model Number	24706
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% to 95% stenosed target lesion was located in the severely calcified vessel in left lower leg.Two 3.0mm x 220mm x 150cm coyote balloon catheter and a 2.0mm x 220mm x 150cm coyote balloon catheter were used for dilatation consecutively.However, during the first inflation before reaching the nominal pressure, the balloons ruptured.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient was fine.
Additional Manufacturer Narrative
Describe event or problem corrected.The devices used were previously reported as "two 3.0mm x 220mm x 150cm coyote balloon catheter and a 2.0mm x 220mm x 150cm coyote balloon catheter were used for dilatation consecutively." which has been corrected to "two 2.0mm x 220mm x 150cm coyote balloon catheter and a 3.0mm x 220mm x 150cm coyote balloon catheter were used for dilatation consecutively.".
Event or Problem Description
It was reported that balloon rupture occurred.The 90% to 95% stenosed target lesion was located in the severely calcified vessel in left lower leg.Two 2.0mm x 220mm x 150cm coyote balloon catheter and a 3.0mm x 220mm x 150cm coyote balloon catheter were used for dilatation consecutively.However, during the first inflation before reaching the nominal pressure, the balloons ruptured.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient was fine.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% to 95% stenosed target lesion was located in the severely calcified vessel in left lower leg.Two 2.0mm x 220mm x 150cm coyote balloon catheter and a 3.0mm x 220mm x 150cm coyote balloon catheter were used for dilatation consecutively.However, during the first inflation before reaching the nominal pressure, the balloons ruptured.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient was fine.
Additional Manufacturer Narrative
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 contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole 39mm proximal from the distal marker band.Inspection of the remainder of the device presented no other damage or irregularities.Describe event or problem corrected.The devices used were previously reported as "two 3.0mm x 220mm x 150cm coyote balloon catheter and a 2.0mm x 220mm x 150cm coyote balloon catheter were used for dilatation consecutively." which has been corrected to "two 2.0mm x 220mm x 150cm coyote balloon catheter and a 3.0mm x 220mm x 150cm coyote balloon catheter were used for dilatation consecutively.".

• 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: 8870935
• Report Number: 2134265-2019-08839
• Device Sequence Number: 3294299
• Product Code: DQY
• UDI-Device Identifier: 08714729797265
• UDI-Public: 08714729797265
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 09/13/2019

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: 06/11/2022
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0023939021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 07/18/2019; 08/23/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 08/09/2019; 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR