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

Catalog Number	AB35W12060080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2019
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 an evercross device.No embolic protection was used.The device was prepped with no issues.It was reported that a balloon burst occurred during balloon inflation at nominal pressure while using an inflation device with hep and saline.All fragments of the balloon were retrieved.The device did not pass through a previously deployed stent, no resistance was encountered while advancing the device and no excessive force was used.The balloon was removed and two more evercross devices were used.It was reported that a balloon burst occurred with both of these devices during inflation at nominal pressure and both balloons removed from the patient.A fourth evercross was used to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: device used in the patient¿s brachial vein during treatment of fistulogram exhibiting 30-40% stenosis.Non-medtronic introducer sheath and guidewire were used during the procedure.A mixture of hepsaline with contrast was used to inflate the pta balloon.Procedures were completed using new balloon of same size.One device , not three, were used in this procedure product analysis: the evercross dilatation catheter was received for evaluation.No ancillary devices or cine images from the procedure were received for evaluation.The evercross dilatation catheter was received with the balloon chamber in a post-inflation profile, (e.G.Not tightly wrapped or winged).Sanguine residue was noted within the balloon chamber.A 10cc water filled syringe was attached to the proximal hub luer lock of the y-manifold and the guidewire lumen was flushed; a clear steady stream of fluid was observed exiting the distal tip of the catheter.A 0.035¿ guidewire was loaded with ease through the distal tip of the catheter and navigated out the proximal hub of the y-manifold.A 10cc water filled syringe was attached to the inflation lumen luer lock of the y-manifold.The balloon chamber was inflated, and a pinhole leak was located in the balloon.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: 8292224
• Report Number: 2183870-2019-00048
• Device Sequence Number: 1370885
• Product Code: LIT
• UDI-Device Identifier: 00821684062333
• UDI-Public: 00821684062333
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/04/2019

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: 09/22/2021
• Device Catalogue Number: AB35W12060080
• Device Lot Number: A712188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1