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

Model Number	24706
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that balloon deflation failure occurred.The target lesion was located in the left anterior tibial artery.A 2.0mm x 220mm x 150cm coyote balloon catheter was advanced and was inflated at 8 atmospheres for 30 seconds.However, it was noted that the balloon would not deflate.After numerous negatives pulled with the encore 26 inflation device and 10cc syringes, the balloon deflated and was completely removed from the body intact.It took an extra minute to remove the balloon from the patient due to multiple negatives being pulled on the balloon.The procedure was completed with another coyote balloon catheter.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon deflation failure occurred.The target lesion was located in the left anterior tibial artery.A 2.0mm x 220mm x 150cm coyote balloon catheter was advanced and was inflated at 8 atmospheres for 30 seconds.However, it was noted that the balloon would not deflate.After numerous negatives pulled with encore 26 inflation device and a 10cc syringes, the balloon deflated and was completely removed from the body intact.It takes an extra minute to remove the balloon from the patient due to multiple negatives being pulled on the balloon.The procedure was completed with another coyote balloon catheter.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
B3 date of event: updated from (b)(6) 2020 to (b)(6) 2020.

• 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: 10198197
• Report Number: 2134265-2020-07968
• Device Sequence Number: 14011904
• Product Code: DQY
• UDI-Device Identifier: 08714729796466
• UDI-Public: 08714729796466
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 07/14/2020

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: 05/07/2022
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0023757956
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1