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

Catalog Number	AB35W06040080
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/09/2017
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
The physician was attempting to use an evercross pta balloon catheter in a patient when the balloon burst.The balloon was removed from the patient but a portion of the balloon remained in the patient.A stent was deployed to jail the balloon fragment against the wall of the artery.
Additional Manufacturer Narrative
Evaluation summary the evercross dilatation catheter was returned for evaluation.A portion of 6mm by 40mm balloon chamber material, inner guidewire lumen approximately 40mm including the distal tip, and two balloon chamber radiopaque marker bands were not returned.No ancillary devices or cine images from the procedure were received.The balloon chamber material separation face appears to be a radial tear within the proximal balloon chamber cone and the inner guidewire lumen separation exhibits a tensile separation at the proximal end of the proximal radiopaque marker band.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Event description updated with additional information inflation atm was reported as 8 atm which is below the rbp for this device (14 atm) a 6fr sheath and a 0.035 guidewire was used in the procedure no embolic protection was used the physician used a new balloon and it worked with no issues reported.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: 6915750
• Report Number: 2183870-2017-00426
• Device Sequence Number: 482816
• Product Code: LIT
• UDI-Device Identifier: 00821684061619
• UDI-Public: 00821684061619
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2018

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: 08/05/2019
• Device Catalogue Number: AB35W06040080
• Device Lot Number: A322765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Initial Date Received by Manufacturer: 09/09/2017
• Supplement Date Received by Manufacturer: 11/09/2017; 02/21/2018
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 12/08/2017; 03/21/2018
• 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