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

Catalog Number	AB35W05100135
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2018
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
It was reported that the physician used an evercross balloon with a 6fr non-mdt sheath and 0.035" non-mdt guidewire for treatment of a 100mm cto (chronic total occlusion-100%) calcified lesion in the distal right superficial femoral artery(sfa) of diameter 6mm.The vessel was reported to be slightly tortuous.The ifu was followed and the device was prepped without issue.A non-mdt inflation device was used.The device did not pass through a previously deployed stent, no excessive force was used and there was no resistance encountered.It was reported that, following the first inflation, deflation issues were noted.The physician pulled negative several times on the inflation device tried a new one with no success.The physician also attempted pulling negative with a 20cc syringe without success.The balloon eventually deflated enough after more than 5 mins so that the physician was able to pull it into the sheath.This slowly deflated the balloon sufficiently to be able to remove it.No patient injury was reported.
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.A small amount of a viscus clear fluid was observed in the balloon chamber.A 20cc water-filled syringe was attached to the proximal hub luer lock and the guidewire lumen was flushed: a clear steady stream of fluid was observed exiting the distal end of the dilatation catheter.A 0.035¿ compatible guidewire was loaded with ease through the distal tip of dilatation catheter and navigated out the proximal hub luer lock.A 20cc water-filled syringe with manometer was attached to the inflation lumen luer lock on the y-manifold.The evercross dilatation catheter was inflated to a rated burst pressure (rbp) of 18 atm.A vacuum was drawn to deflate the balloon chamber.The balloon chamber would not deflate under sustained vacuum for just over five minutes.The proximal end of the balloon chamber was examined.The proximal balloon bond appeared to be necked down to the inner guidewire lumen and not providing an optimum deflation pathway.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: 7618635
• Report Number: 2183870-2018-00337
• Device Sequence Number: 1589812
• Product Code: LIT
• UDI-Device Identifier: 00821684061473
• UDI-Public: 00821684061473
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 09/12/2018

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: 10/01/2020
• Device Catalogue Number: AB35W05100135
• Device Lot Number: A532724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1