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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture had occurred.A tibialplasty procedure was being performed.The 2.5mm x 80mm x 150cm coyote balloon ruptured on the first inflation at nominal pressure.The procedure was successfully completed with a different device without issue or patient injury.
Additional Manufacturer Narrative
Device returned to manufacturer: the 2.5mm x 80mm x 150cm coyote balloon catheter was returned and analysis was completed.The investigation found the balloon to be loosely folded and the device was bloody.Analysis of the tip, balloon, markerbands, inner and outer shaft included microscopic and visual inspection.Analysis revealed a pinhole in the balloon material that was 77mm from the tip of the device, and the tip was damaged.The hole in the balloon confirmed the complaint of the balloon having ruptured.Inspection of the rest of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that a balloon rupture had occurred.A tibialplasty procedure was being performed.The 2.5mm x 80mm x 150cm coyote balloon balloon ruptured on the first inflation at nominal pressure.The procedure was successfully completed with a different device without issue or patient injury.

• 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: 9274201
• Report Number: 2134265-2019-13308
• Device Sequence Number: 11677517
• Product Code: DQY
• UDI-Device Identifier: 08714729797180
• UDI-Public: 08714729797180
• 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): 12/06/2019

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: 10/30/2021
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0022868814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR