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

Catalog Number	8700-0791-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2017
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 patient was inserted a quattro catheter without issue and received ivtm therapy.Approximately 20 hours into treatment, the thermogard console (sn (b)(4)) displayed an airtrap alarm.Upon examination, the user observed signs of leak around the patient's bedside likely caused by a leak on the catheter or start-up kit (suk); however, could not be conclusively determined and a catheter leak could not be ruled out at this time.Since the target temperature of 34°c had already been achieved, the catheter was removed from the patient and no further temperature management was administered.No known impact or patient consequence was reported.This references the report of a suspected leak on the catheter.Reference mfr 3010617000-2018-00035 for the report of an airtrap alarm on the thermogard console.
Additional Manufacturer Narrative
The reported catheter leak was not confirmed.No balloon leak observed on catheter.No leakage due to crosstalk observed.All lumens flushed as intended.During functional testing, the catheter was connected to a pressurized inflation device and no leakage was observed.During manufacturing all catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed related to quattro catheter lot # 75725 and no previous complaint was identified.

• 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: 7187822
• Report Number: 3010617000-2018-00101
• Device Sequence Number: 63346
• Product Code: NCX
• UDI-Device Identifier: 00849111075503
• UDI-Public: 00849111075503
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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 Catalogue Number: 8700-0791-01
• Device Lot Number: 75725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 01/12/2018
• 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: 50 YR
• Patient Weight: 80