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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM QUATTRO CATHETER; CENTRAL VENOUS CATHETER
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ZOLL CIRCULATION ZOLL IVTM QUATTRO CATHETER; CENTRAL VENOUS CATHETER Back to Search Results
Catalog Number 8700-0660-01
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/09/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The zoll catheter was returned to zoll for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
 
Event or Problem Description
It was reported that during patient therapy with the thermogard tgxp, it was observed two bags of saline had emptied and catheter leak was suspected.Catheter was replaced, however, no additional information was provided.There is no report of patient impact or consequences.
 
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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 Key7575974
Report Number3010617000-2018-00614
Device Sequence Number19286079
Product Code NCX
UDI-Device Identifier00849111075138
UDI-Public00849111075138
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K101987
Number of Events Summarized1
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) 06/06/2018
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 Catalogue Number8700-0660-01
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/08/2018
Initial Report FDA Received Date06/06/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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