MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ZENYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER BASIC KIT (11F); CATHETER, HEMODIALYSIS, DUAL LUMEN, NON-IMPLANTED

Catalog Number	A863150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a kink was confirmed, but the exact cause is unknown.A photograph of what appears to be a zensysis catheter was provided for investigation.The image shows a photograph of an (b)(6) that has the image of an implanted dialysis catheter inserted in what could be the right internal jugular (ij) vein.A white towel is draped over the shoulder of the patient.Both extension legs of the catheter are full of what appears to be blood residue.The extension legs are being held parallel to the side of the patient¿s neck with a gloved hand.It cannot be determined if the extension legs are pre-curved or straight.A full view of the connectors is not available.Sutures are tied through the suture wing at the bifurcation.Blood residue is visible on a small area of the molded bifurcation.It appears that the d/l tubing is kinked at the exit site, approximately 0.5cm ¿ 1cm from the distal end of the bifurcation.Blood residue is visible on the d/l tubing.It appears that the exit site is sutured closed.A longitudinal line of blood residue is visible on the d/l tubing near the kink.It cannot be determined if the tubing is breached at that location.The kink in the catheter could be related to how the catheter is positioned and secured near the exit site.The product ifu states, ¿catheters should be implanted carefully to avoid any sharp or acute angles which could compromise the opening of the catheter lumens.¿ a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
On 08/16/2016- per sales representative, the facility reported an issue with a zenysis dual lumen catheter that was inserted in a patient.On (b)(6) 2016 - the picture received appears to show a split in the catheter near the insertion site.On (b)(6) 2016 - per the sales representative: "the catheter is completely kinked over at the base of the hub where the catheter shaft begins.You can see the septum between the two lumens where there is pressure on the catheter." on 08/18/2016- additional information from sales representative stated, "catheter bending/kinking just below hub where secured by sutures impairing the catheter's ability to flow.The sutures had to be cut and catheter straightened out to use.No patient injury reported.This report is regarding patient 2.

• Brand Name: ZENYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER BASIC KIT (11F)
• Common Device Name: CATHETER, HEMODIALYSIS, DUAL LUMEN, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5906668
• Report Number: 3006260740-2016-00463
• Device Sequence Number: 16347365
• Product Code: MPB
• UDI-Device Identifier: 00801741109775
• UDI-Public: (01)00801741109775
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2016

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 Catalogue Number: A863150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2016
• Initial Report FDA Received Date: 08/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1