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

Catalog Number	AB35W07200135
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2018
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 attempted to use an evercross balloon to treat a severely calcified lesion with cto (chronic total occlusion-100%) in the mid- superficial femoral artery (sfa).The vessel presented moderate tortuosity.Ifu was followed and the device was prepped with no issues noted.It was reported that a pin hole balloon burst during inflation to 8 atm.All fragments were retrieved from the patient.The procedure was completed with another balloon.No injury was reported.
Additional Manufacturer Narrative
Additional information: contrast and heparinised saline were used to inflate the balloon.No issues were noted when withdrawing the balloon from the patient.The procedure was completed by carrying out a planned stenting and then ballooning.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 8149943
• Report Number: 2183870-2018-00576
• Device Sequence Number: 1579568
• Product Code: LIT
• UDI-Device Identifier: 00821684061978
• UDI-Public: 00821684061978
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup,Followup
• Report Date (Section B): 02/26/2019

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: 10/29/2021
• Device Catalogue Number: AB35W07200135
• Device Lot Number: A731629
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 12/11/2018; 02/25/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 12/14/2018; 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1