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

Model Number	8700-0660
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2016
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 site reported; quattro catheter was inserted in the patient for the purpose of treating post cardiac arrest.It was noticed a while later that the saline level was low.The operation of a thermogard was suspended and the catheter was removed.A new quattro catheter was inserted in the patient and the thermogard was restarted.With the second catheter, the saline level did not decrease.Treatment was continued.There is no health injury to the patient.
Additional Manufacturer Narrative
The quattro catheter s/n: (b)(4) was returned to zoll (b)(4) for evaluation.Historical complaints were reviewed for service information related to the reported complaint and there were no previous history of complaints reported for quattro catheter lot # 62752.Upon receipt, a visual inspection for the returned catheter found the catheter was cut from the tubings, traces of desiccated blood in the balloons, shaft, luered tubings and infusion ports.With the condition of the catheter as received, the functional testing of the catheter could not be performed.As the evaluation was not performed on returned device, reported complaint cannot be determined.

• Brand Name: ZOLL IVTM XXXX CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5995587
• Report Number: 3010617000-2016-00699
• Device Sequence Number: 697540
• Product Code: NCX
• UDI-Device Identifier: 00849111050050
• UDI-Public: 00849111050050
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2016

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 Expiration Date: 03/08/2018
• Device Model Number: 8700-0660
• Device Catalogue Number: 8700-0660-03
• Device Lot Number: 62927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2016
• Supplement Report FDA Received Date: 10/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1