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 Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 4mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during first inflation at nominal pressure, the balloon ruptured.No patient complications were reported.Returned product consisted of a coyote es balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination did not reveal any damages.Microscopic examination revealed two pinholes in the balloon located 14mm and 15mm away from the tip.There is blood present in both the balloon and inflation lumen.Further investigation revealed that the tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there are two pinholes in the balloon.The investigation conclusion code is adverse event related to procedure.

• 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: 7922146
• Report Number: 2134265-2018-61441
• Device Sequence Number: 1586333
• Product Code: LIT
• UDI-Device Identifier: 08714729767459
• UDI-Public: 08714729767459
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080982
• 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): 10/01/2018

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: 06/28/2020
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0022318807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1