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

Catalog Number	AB35W05040135
Medical Device Problem Codes	Deflation Problem (1149); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the evercross 0.035in otw pta dilatation catheter was received for evaluation.No ancillary devices or cine images from the procedure were received.The evercross dilatation catheter was received with the balloon chamber in a post-inflation profile with crystalline residue noted within the balloon chamber and inflation pathway.Attempts to initially inflate the balloon at rated burst pressure, 18atm, were not successful.Post sonication in a 30c sonication bath, the crystalline residue from the pathways cleared and the device was inflated with a 50:50 glycerin:water solution to rated burst pressure.Full deflation occured in 11seconds.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 balloon with a non-mdt inflation device.The ifu was followed and the device was prepped without issue.No embolic protection was used.It was reported that balloon deflation difficulties were experienced following the first inflation.The balloon was able to be removed from the sheath.No patient injury was reported.
Additional Manufacturer Narrative
Additional information received (b)(6) 2018: physician intended to use the evercross balloon to treat a lesion in the femoral artery, post dilation.Resistance was not encountered when advancing the device.It was reported that nominal pressure was applied to the device.The balloon was able to be deflated, after some time.No intervention was required to remove the device.The physician used another balloon to complete the procedure without further difficulty.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: 7521363
• Report Number: 2183870-2018-00280
• Device Sequence Number: 1626712
• Product Code: LIT
• UDI-Device Identifier: 00821684061398
• UDI-Public: 00821684061398
• 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): 06/12/2018

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: 03/13/2021
• Device Catalogue Number: AB35W05040135
• Device Lot Number: A612941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1