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

Catalog Number	AB35W06080135
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: the evercross dilatation catheter was received for evaluation.The evercross dilatation catheter was received in three pieces and not all the components of the dilatation catheter were returned.A radiopaque marker, distal tip, and balloon chamber material were not returned.Only a small portion of the proximal balloon cone material was received attached to the dilatation catheter.The returned balloon chamber material exhibited circumferential and longitudinal tearing.Two fragments of the inner guidewire lumen were returned.The longer segment had one of radiopaque marker bands still attached.Both inner guidewire lumen segments exhibit stretching and kinking.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The procedure being performed used two 6x80 mm evercross pta balloons to pre-dilate lesions in a patient¿s common iliac arteries at the same time.The devices were prepped as per the ifu with no issues identified.The procedure used a 30 cm 6 fr non-medtronic sheath and a 0.035¿ 260cm non-medtronic guidewire.The evercross dilations in the common iliac arteries inflated without incident.Two visipro balloon expandable stents were then deployed without incident in each of the iliac arteries.One of the 6x80 mm evercross balloons was then used in the right external iliac artery.The lesion was 80 mm in length and severely calcified (resulting in 70% stenosis).The artery was 6 mm in diameter and had little tortuosity.It was reported that the balloon burst longitudinally at 6-8 atm.The device did not pass through a previously deployed stent.No excessive force was used.After the balloon ruptured the physician had difficulty removing it.In the process the catheter broke apart leaving a portion in the patient/sheath.It appeared to be in multiple pieces.The balloon was still on the wire and a 10mm gooseneck snare was advanced from the left side to snare the wire to keep the parts from coming off when the sheath with parts of the catheter was removed.It was reported that the sheath was pulled out but the snare did not hold the wire enough and a small part became lodged in the tissue.An incision was made in the right groin and was able to remove a small portion of catheter.After imaging to locate the fragments of the balloon, it was decided to place a stent over the area where the balloon ruptured.Imaging of the right leg did not reveal any other fragments and good flow to the foot.No patient injury was reported.

• 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: 7220922
• Report Number: 2183870-2018-00042
• Device Sequence Number: 11094994
• Product Code: LIT
• UDI-Device Identifier: 00821684061671
• UDI-Public: 00821684061671
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2019
• Device Catalogue Number: AB35W06080135
• Device Lot Number: A272684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 80