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

Catalog Number	AB35W10040080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use an evercross device with a 7fr sheath and non-mdt 0.035 angled guidewire during the treatment of a moderately calcified fibrous lesion in the mid right subclavian vein.It was reported that the ifu was followed and the device was prepped without issue.It was also reported that during the second inflation of the balloon, at an inflation pressure of 10 atm, the balloon burst.Following this, there were difficulties removing the balloon as the tip of the balloon catheter broke off.The broken tip was stuck to the wire and had to be snared for removal.No patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the evercross device was returned for evaluation.No ancillary devices were included.Visual inspection: the evercross was inspected.The balloon showed a radial burst with the catheter fractured off within the balloon segment.Approximately 3.5cm of the balloon remained on the catheter.No marker bands were found on the catheter.The working length of the catheter was approximately 76 cm.Under microscope the distal edge of the catheter was inspected and the fracture face was flat and showed the color of the catheter lighten, consistent with material stretching.The distal segment of the evercross catheter which had been snared was not returned.The product labeling for the evercross unit associated to lot a545679 indicates a balloon length of 4cm and a working length of 80cm.No functional testing could be conducted on this returned device.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: 7513950
• Report Number: 2183870-2018-00272
• Device Sequence Number: 16816127
• Product Code: LIT
• UDI-Device Identifier: 00821684062258
• UDI-Public: 00821684062258
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2020
• Device Catalogue Number: AB35W10040080
• Device Lot Number: A545679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 06/20/2018; 08/08/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 07/18/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR