MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM SOLEX CATHETER; CENTRAL VENOUS CATHETER

Model Number	SL-2593
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The solex catheter was placed in an unapproved site (femoral vein).The solex is approved only for subclavian or jugular veins.Also, placing two catheters (solex and a dialysis catheter) appears to be an unusual practice.The contribution of dialysis catheter to the reported difficult cannot be determined or ruled out based on available information.It is also important to note that the user did not follow the catheter deflation procedure prior to withdrawal.The ifu states that the out flow lumen should be capped for a proper deflation of the catheter.Not capping the lumen allows air to seep in through the outflow lumen as the syringe pulls vacuum on the inflow luer.
Event or Problem Description
On (b)(6) 2017, a (b)(6) female patient began temperature management therapy after experiencing a second cardiac arrest while in the icu.A solex catheter was placed in the patient's right femoral vein without issue.A dialysis catheter was placed in the same vein from (b)(6) 2017 to (b)(6) 2017.The cause of the patient's kidney failure is not known.After completing temperature management therapy, the attending nurse and intensivist reported experiencing resistance upon removing the solex catheter.Ultimately, the health care team decided to have the solex catheter removed surgically.According to the attending physician, the solex catheter was later removed with the tip intact.After the removal, the physician noted there were no major bleeding.The physician believes it was due to a fair amount of venous clot around the catheter that was protruding out through the venotomy.The venous clot was extracted and the physician suture closed the 2 sutures.The patient remained stable and was eventually returned to the icu.According to the clinical specialist, it was later discovered that the solex catheter was not fully deflated upon removal.The attending nurse and intensivist aspirated the saline from the catheter; however, did not perform the recommended vacuum seal.
Additional Manufacturer Narrative
During visual inspection of the returned solex catheter (lot# 67830), damaged balloons were noted; however the balloons were not detached from the shaft.The guidewire lumen was noted to be clogged with blood.During functional testing, the returned catheter was connected to a pressurized inflation device and pressure was increased and a pinhole leak was noted at the proximal end and medial balloon.Historical complaints were reviewed and one similar complaints were reported for solex catheter (lot # 67830) for a catheter resistance, under ccr 30130 reported on (b)(6) 2017.The customer reported complaint was not confirmed.Evaluation of the returned solex catheter indicated that the catheter performed as per specification.

• Brand Name: ZOLL IVTM SOLEX CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 6791873
• Report Number: 3010617000-2017-00672
• Device Sequence Number: 19102726
• Product Code: NCX
• UDI-Device Identifier: 00849111075152
• UDI-Public: 00849111075152
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2017

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 Model Number: SL-2593
• Device Catalogue Number: 8700-0671-01
• Device Lot Number: 67830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR