MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM SOLEX 7CATHETER; CENTRAL VENOUS CATHETER

Model Number	SL-2593
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's reported complaint was not confirmed during functional testing.Evaluation of the returned solex catheter indicated that the catheter performed as per specifications.All lumens flushed as intended.No leaks were noticed during flushing or inflation.Per solex catheter instruction for use has special instructions that never use excessive force in moving the catheter or guidewire.If resistance is encountered, an x-ray should be performed to identify the reason for the resistance.Functional test of returned catheter was performed; all infusion ports and extension tubes were flushed without resistance.The catheter was connected to a pressurized inflation device; the balloons fully inflated when pressurized up to 100psi without any issues.The balloons did not leak during inflation and deflation.A visual inspection of the returned catheter was performed.The balloons were examined and there were no tears, balloon bond detachment or rupture noted.Blood had accumulated /dried up on the balloons, shaft, luered tubings and infusion ports.During manufacturing, all solex catheters are 100% inspected.Only units that passed are moved to the next process.Historical complaints were reviewed for service information related to the reported complaint and there were no previous history of complaints reported for solex catheter lot # 67830.
Event or Problem Description
It was reported that the patient was hospitalized for post cardiac arrest and required therapeutic hypothermia.A solex catheter was inserted into the right internal jugular vein.The catheter insertion was described as difficult but was inserted in one attempt by the physician.After inserting the dilator, the physician attempted to pass the catheter but met significant resistance.The physician stopped and pulled the catheter back.The catheter was removed and another solex 7 catheter was placed which was inserted without any issues.The cooling therapy was continued successfully.There were no patient sequaela reported.Per reporter, the physician indicated that the catheter looked as it normally prior to insertion.Nothing was done with the catheter prior to insertion.The physician did not think she reached the vessel with the catheter prior to reaching resistance and thought it was likely still subcutaneous when resistance was met.The staff checked the balloons after the fact and there was one that they believed looked different.

• Brand Name: ZOLL IVTM SOLEX 7CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 6308921
• Report Number: 3010617000-2017-00108
• Device Sequence Number: 13563714
• Product Code: NCX
• UDI-Device Identifier: 00849111075152
• UDI-Public: 00849111075152
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2017

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2017
• Initial Report FDA Received Date: 02/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1