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

Catalog Number	AB35W07080080
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
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.
Event or Problem Description
It was reported that the physician intended to use an evercross 035 balloon in a fistulogram procedure in the brachial veins described as approx.30-40% stenosis.There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop.The device was prepped with no issues identified.No embolic protection was used.A non-medtronic 7f sheath and a 0.035 non-medtronic wire platform was used.The device was inflated once to nominal pressure with hep saline used as inflation fluid.The device did not pass through a previously deployed stent, no resistance was encountered and no excessive force used on advancing the device to the target lesion.The evercross 035 balloon ruptured during the first inflation.All fragments of the balloon were retrieved.Another medtronic balloon of the same size was used to complete the procedure successfully.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: burst occurred prior to reaching nominal pressure.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device 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: 8389431
• Report Number: 2183870-2019-00111
• Device Sequence Number: 1432572
• Product Code: LIT
• UDI-Device Identifier: 00821684061886
• UDI-Public: 00821684061886
• 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,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: 08/20/2021
• Device Catalogue Number: AB35W07080080
• Device Lot Number: A695514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 03/11/2019; 05/10/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 03/26/2019; 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1