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

Model Number	8700-0782-01
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported icy catheter leak was not confirmed.Visual inspection of the returned catheter was performed and found no physical damage to the catheter.The balloons were examined and there were no tears, balloon bond detachment or rupture noted.Functional testing of the 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 100 psi without any issues.The balloons did not leak during inflation and deflation.No leak was observed.All lumens flushed as intended.During manufacturing, all catheters are 100 % inspected for leaks by subjecting them to pressure testing.Only units that pass are moved to the next process.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for a catheter with a lot number 79865.
Event or Problem Description
On (b)(6) 2019, zoll received a medwatch report mw5082215: "hypothermia catheter failed during use - ns fluid level noted to be decreasing." based on the follow-up information, the patient was hospitalized and underwent treatment for hypothermia.The icy catheter was inserted on (b)(6) 2018 at (b)(6) pm without issue in the right femoral vein.Following day, the saline bag was noted low in volume.No leak was observed at the site and the catheter leak was suspected.The catheter was replaced on (b)(6) 2018 at (b)(6) am to continue with therapy.No known impact or patient consequence information was available.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8295046
• Report Number: 3010617000-2019-00066
• Device Sequence Number: 13828051
• Product Code: NCX
• UDI-Device Identifier: 00849111075237
• UDI-Public: 00849111075237
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K770977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2019

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: No Information
• Device Model Number: 8700-0782-01
• Device Catalogue Number: 8700-0782-01
• Device Lot Number: 79865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1