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	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon ruptured occured.The target lesion was located in the non tortuous and severely calcified posterior tibial artery.Several coyote balloon catheters were advanced and used during this procedure (3.0mm x 220mm x 150cm, 2.5mm x 150mm x 150cm, 2.0mm x 60mm x 150cm and 3.0mm x 150mm x 150cm) however, the balloons blew out at nominal pressure.The 1st coyote balloon ruptured on the 2nd inflation at 10 atm.The 2nd, 3rd and 4th coyote balloons ruptured on the1st inflations at 6 atm.The procedure was completed with different device.No known patient complication were 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: 8464547
• Report Number: 2134265-2019-03198
• Device Sequence Number: 1436361
• Product Code: DQY
• UDI-Device Identifier: 08714729796732
• UDI-Public: 08714729796732
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

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: 09/20/2021
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0022686125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR