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

Model Number	8700-0660-01
Medical Device Problem Codes	Leak/Splash (1354); Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
The nurse reported that approximately 6 to 7 hours into the ivtm treatment (patient cooling), evidence of leak was observed on the floor and a tinge of blood was observed on the start-up kit (suk) tubing suspecting leak on the icy catheter.No alarm was observed on the console.Following this, the console was placed on standby and another icy catheter was inserted to continue the patient treatment.No known impact or patient consequence was reported.A medwatch report mfr (b)(4) submitted by the facility on (b)(6) 2018 was received by zoll on (b)(6) 2018 via postal mail.The report states the following: "catheter placed early evening and cooling initiated an hour and ten minutes later.Rn noted fluid in the thermogard xp system to become red tinged and immediately stopped therapy.Notified icu fellow at six hours after cooling was initiated and catheter exchanged.The device did not do what it was supposed to do." additional information on the report states that the event involved a (b)(6) female patient.No other information was reported.
Additional Manufacturer Narrative
The reported leak was confirmed.Visual inspection of the returned catheter found the distal luer cut from the catheter.No other abnormalities on the catheter were seen.All other lumens flushed as intended.During functional testing, the catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a pin hole leak was observed medial to the distal balloon.During manufacturing all icy catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Probable causes for the reported complaint can be a latent material defect.Historical complaints were reviewed related to reported complaints on icy catheter lot# 71420; there was no previous complaint history for the lot number.

• 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: 7266863
• Report Number: 3010617000-2018-00159
• Device Sequence Number: 1736975
• Product Code: NCX
• UDI-Device Identifier: 00849111075138
• UDI-Public: 00849111075138
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 04/11/2018

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: 8700-0660-01
• Device Catalogue Number: 8700-0660-01
• Device Lot Number: 71420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR