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

Model Number	24701
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon tear was encountered.A 3mm x 20mm x 143cm coyote es balloon catheter was selected for use.However, upon opening the package, it was noticed that the balloon had a tear.The procedure was completed with a 3x30 coyote balloon catheter.No further complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.:returned product consisted of a coyote es balloon catheter.There was no visible damage.Functional testing was completed by connecting a water filled inflation device to the hub and pressurizing the catheter.The water was streaming from the tip.Microscopic examination of the device revealed a hole in the inner shaft by the balloon weld.
Event or Problem Description
It was reported that balloon tear was encountered.A 3mm x 20mm x 143cm coyote es balloon catheter was selected for use.However, upon opening the package, it was noticed that the balloon had a tear.The procedure was completed with a 3x30 coyote balloon catheter.No further complications reported.

• Brand Name: COYOTE ES
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9256789
• Report Number: 2134265-2019-13015
• Device Sequence Number: 19817102
• Product Code: LIT
• UDI-Device Identifier: 08714729767398
• UDI-Public: 08714729767398
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K093636
• 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): 01/15/2020

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 Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0023673329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1