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

Catalog Number	AB35W07080135
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2019
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 intended to use the evercross balloon was to be used to treat a lesion in the left mid sfa.No damage was noted to packaging, no issues noted when removing device from hoop/tray.The device was prepped per the ifu with no issues.The device passed through a previously deployed stent, no stent interaction was reported, no resistance was encountered when advancing the device and no excessive force was used.It was reported the physician was unable to inflate the balloon whilst in the patient, it is unknown where the leak is on the balloon.The procedure was completed with another balloon.No patient injury.
Additional Manufacturer Narrative
Device evaluation the evercross was removed from the packaging and inspected.Dried blood was observed on the outside of the balloon segment.There was no indication the balloon inflated previously.No damages to the returned evercross was observed.Functional testing: a 0.014" guidewire from the lab was attempted to be front loaded; however, a blockage was encountered.Likely due to dried contrast and/or biologics within the gw lumen (not related to the reported event).An inflation device from the lab filled with water was connected to the balloon port of the manifold.At approximately 8 atm, the balloon had inflated.No signs of leaks were noted.With the evercross soaked in water and constant pressure (14 atm) administered to the balloon for approximately 12 hours.The balloon remained inflated.The balloon was squeezed between two fingers and found no leak.Negative pressure was applied to the balloon and the balloon was able to deflate.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: 8381446
• Report Number: 2183870-2019-00105
• Device Sequence Number: 1634347
• Product Code: LIT
• UDI-Device Identifier: 00821684061893
• UDI-Public: 00821684061893
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/20/2019

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: 06/17/2021
• Device Catalogue Number: AB35W07080135
• Device Lot Number: A662717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR