MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	AB35W08040135
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use an evercross balloon dilation catheter to treat a moderately calcified mid right common iliac artery.The vessel had little tortuosity and the lesion had resulted in 90% stenosis.The device was prepped with no issues identified.There was no resistance encountered advancing the device and it did not pass through a previously deployed stent.During the first balloon inflation at 7atm the balloon burst.The procedure used a non-mdt inflation device.There were no balloon fragments.All of device was withdrawn from the patient without intervention.The artery was stented with a 10x40 protege, and post dilated with a competitive balloon to complete the procedure.The use of the protege was planned.No patient injury was reported.

• Brand Name: EVERCROSS 035
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7780070
• Report Number: 2183870-2018-00413
• Device Sequence Number: 1705775
• Product Code: LIT
• UDI-Device Identifier: 00821684062050
• UDI-Public: 00821684062050
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082579
• 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): 08/14/2018

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: 03/29/2021
• Device Catalogue Number: AB35W08040135
• Device Lot Number: A621443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 100