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	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age of time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via femoral artery.The 70% stenosed, 60mmx2mm, concentric target lesion was located in the non-tortuous and non-calcified posterior tibial artery.A 2.0mm x 60mm x 150cm coyote balloon catheter was advanced for dilatation.However, upon inflation at 8 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Age of time of event: 18 years or older.Device evaluated by mfr.: returned product consisted of a coyote balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were kinks 66cm, 1.9cm, and 1.3cm distal from the strain relief.There was contrast in the inflation lumen, and blood in the guidewire lumen.The balloon was tightly folded.Microscopic inspection revealed 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.Vascular access was obtained via femoral artery.The 70% stenosed, 60mmx2mm, concentric target lesion was located in the non-tortuous and non-calcified posterior tibial artery.A 2.0mm x 60mm x 150cm coyote balloon catheter was advanced for dilatation.However, upon inflation at 8 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

• 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: 8626193
• Report Number: 2134265-2019-05537
• Device Sequence Number: 2232593
• Product Code: DQY
• UDI-Device Identifier: 08714729796732
• UDI-Public: 08714729796732
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 09/30/2019

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: 12/16/2021
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0023091555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1