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

Model Number	24705
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation slow occurred.The 90% stenosed target lesion was located in the severely tortuous and moderately calcified anterior tibial artery.An encore 26 inflation syringe was used to inflate a 3.00mm x 150mm x 90cm coyote balloon catheter.The balloon was inflated and deflated twice and removed from the patient.On the third inflation, the balloon inflated fine but when the physician went to deflate the balloon it was very slow to deflate.The physician filled they syringe with more saline and inflated the balloon a bit more, but deflation was still slow.The physician then pulled back on the balloon a little to straighten the balloon and the balloon suddenly deflated.The procedure was completed as planned using the device.No patient complications 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: 8842866
• Report Number: 2134265-2019-08717
• Device Sequence Number: 16222956
• Product Code: DQY
• UDI-Device Identifier: 08714729797258
• UDI-Public: 08714729797258
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 07/30/2019

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: 05/05/2022
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0023744743
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR