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	10/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The approximately 80% stenosed, medium length target lesion was located in the non-tortuous and highly calcified anterior tibial artery.A 3.0mm x 100mm x 150cm coyote balloon catheter was for dilatation.However, during procedure, the balloon was advanced over the wire into the sheath and it was noticed that the balloon appeared not wrapped, as if it had been inflated then deflated.The physician noticed blood coming out from the inflation port, he then removed the balloon from the sheath.An encore 26 inflation device was attached to the inflation port of the balloon and pulled negative, and the inflation device started to fill with air.The procedure was completed with another coyote balloon.There were no complications and the patient's status was fine.
Additional Manufacturer Narrative
The returned product consisted of a coyote balloon catheter.A visual and microscopic inspection revealed a pinhole in the inner shaft 42.5cm from the tip.The hole in the inner shaft prevented successful inflation of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The approximately 80% stenosed, medium length target lesion was located in the non-tortuous and highly calcified anterior tibial artery.A 3.0mm x 100mm x 150cm coyote balloon catheter was for dilatation.However, during procedure, the balloon was advanced over the wire into the sheath and it was noticed that the balloon appeared not wrapped, as if it had been inflated then deflated.The physician noticed blood coming out from the inflation port, he then removed the balloon from the sheath.An encore 26 inflation device was attached to the inflation port of the balloon and pulled negative, and the inflation device started to fill with air.The procedure was completed with another coyote balloon.There were no complications and the patient's status was fine.

• 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: 10817668
• Report Number: 2134265-2020-15372
• Device Sequence Number: 11179397
• Product Code: DQY
• UDI-Device Identifier: 08714729796565
• UDI-Public: 08714729796565
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/07/2020

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: 08/06/2023
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0025822359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1