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

Catalog Number	AB35W06040080
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
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 with a 7fr sheath to treat the superficial femoral artery.An inflation device was used to inflate the balloon.Ifu was followed and the device was prepped without issue.It was reported that during removal of the balloon through the sheath it ruptured and the end piece came off.The broken portion remained in the sheath thus allowing it to be retrieved by pulling out the sheath.The procedure was completed without further issue and no parts remained in the patient.No patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the evercross dilatation catheter was received for evaluation.No ancillary devices or cine images from the procedure were received.The dilatation catheter was received in two pieces.The proximal segment included the y-manifold, catheter up to the distal marker band, and proximal balloon bond.The distal segment included the distal marker band, inner guidewire lumen, distal balloon bond, and distal tip.All components of the evercross dilatation catheter with 6mm x 40mm balloon were received and accounted for.The balloon chamber separation face showed a radial tear.The inner guidewire lumen separation face at the distal marker band exhibited a tensional and torsional separation.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: 7969855
• Report Number: 2183870-2018-00468
• Device Sequence Number: 1214384
• Product Code: LIT
• UDI-Device Identifier: 00821684061619
• UDI-Public: 00821684061619
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 01/28/2019

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: 06/12/2021
• Device Catalogue Number: AB35W06040080
• Device Lot Number: A660249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1