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

Model Number	8700-0660-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
A post cardiac arrest patient was inserted a quattro catheter without issue in the femoral vein for therapeutic hypothermia.It was reported by the hospital nurse that during day 3 into ivtm treatment (maintenance phase), the saline bag was observed to be empty and the thermogard console displayed an airtrap alarm.Upon inspection, no trace of blood was observed in the start-up kit including evidence of leak and no issue was found on the thermogard console.The nurse replaced the start-up kit; however, the same issue was observed.Following this the doctor decided to remove the catheter from the patient since the ivtm therapy is already in its maintenance phase.No adjunct therapy was administered.No known impact or patient consequence was reported.No further information was provided.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 6720288
• Report Number: 3010617000-2017-00496
• Device Sequence Number: 16587428
• Product Code: NCX
• UDI-Device Identifier: 00849111075503
• UDI-Public: 00849111075503
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/17/2017

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: 8700-0660-01
• Device Catalogue Number: 8700-0660-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1