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

Model Number	IC-3893AE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter in complaint was returned to zoll on (b)(6) 2017 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
A patient was hospitalized post cardiac arrest and underwent treatment for hypothermia.Patient's temperature prior to the ivtm therapy was 38 degree celsius.The thermogard console was set to a target temperature of 35 degree celsius.No other adjunctive temperature management procedure were performed on the patient.The icy catheter was inserted into the right femoral vein by an experienced physician on (b)(6) 2017.Catheter insertion was smooth.Five days after insertion, the attending health care professional (hcp) noted that the thermogard ivtm console displayed a low fluid alarm and the saline bag had run dry; however, no fluid was observed anywhere around the patient.The patient's temperature when the issue noted was 35.0 degree celsius.The catheter was removed; however, was not replaced.The patient is in a stable condition.There were no reports of patient impact as a result of the reported issue.No further information was provided.
Additional Manufacturer Narrative
Evaluation of the returned icy catheter confirmed the customer reported issue.The root cause was due to a pinhole leaks.Note, during manufacturing, all icy catheters are 100% inspected for leaks.In addition, extension tubing is 100% tested for leaks.Only units that passed are moved to the next process.A visual inspection of the returned catheter found blood had accumulated /dried up on the balloons, shaft, luered tubings and infusion ports.All infusion ports flushed successfully with no issues observed.Functional testing was performed.The catheter was connected to a pressurized inflation device.Capping the "out" luer, the catheter was pressurized from the inflow luer side.The catheter was pressurized up to 100 psi and held briefly before the pressure gradually dropped and pinhole leaks were observed at the medial balloon.Following the test, all balloons deflated successfully without any issues.Historical complaints were reviewed for service information related to the reported complaint and there were no previous history of complaints reported for icy catheter lot # 67723.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 6337257
• Report Number: 3010617000-2017-00130
• Device Sequence Number: 1518409
• Product Code: NCX
• UDI-Device Identifier: 00849111075077
• UDI-Public: 00849111075077
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2017

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: IC-3893AE
• Device Catalogue Number: 8700-0695-40
• Device Lot Number: 67723
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1