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

Catalog Number	AB35W09040080
Medical Device Problem Codes	Burst Container or Vessel (1074); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evercross device was returned for evaluation.No ancillary devices were included.A visual inspection was completed.The evercross balloon was in a post inflated state and dried blood and a clear crystalized substance (likely contrast) was observed within the balloon.No longitudinal tear was observed.Functional testing was performed.A 10ml syringe filled with water was connected to the balloon port and the plunger was pressed.The balloon inflated, but a spray of water was coming from the proximal end of the balloon.The spray of water was coming out approximately 5cm from the distal end of the catheter.Bubbling was observed from the area were the water was spraying out from.Under microscope a pinhole was identified.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a evercross with a 6fr non-medtronic sheath and a non-medtronic 0.035" glidewire to treat a 25mm fibrous lesion with 75% stenosis in the mid aterial/venous graft of diameter 9mm.The ifu was followed and the device was prepped without issue.The balloon was inflated using a non-medtronic inflation device with a 50/50 mixture of contrast and normal saline.It was reported that the balloon was inflated to 11 atm and ruptured.It appears that it was a longitudinal crack.All of the balloon was removed from the patient and none was left behind in the patient.The procedure was completed using a fortrex balloon, of the same size, without further issue.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: 7892980
• Report Number: 2183870-2018-00446
• Device Sequence Number: 19309987
• Product Code: LIT
• UDI-Device Identifier: 00821684062159
• UDI-Public: 00821684062159
• 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): 09/20/2018

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: 11/27/2020
• Device Catalogue Number: AB35W09040080
• Device Lot Number: A561883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1