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

Model Number	IC-4593
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	02/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device associated with this complaint will not be returned for evaluation.Since the device was not returned, physical investigation of the catheter could not be performed and a root cause could not be determined.In the case the device is returned, the complaint will be re-opened to perform an investigation.A patient was hospitalized post cardiac arrest.The quattro catheter was inserted into a patient's femoral vein on (b)(6) 2018.The insertion was smooth.After insertion, blood flashes were observed in balloon line.Customer reported that the patient had a bleeding disorder, which thought was the reason there was an issue with placing the line as this would be a contraindication.The patient was declared deceased on (b)(6) 2018.Line was not removed- it was still in the patient when the patient went to the medical examiner.According to the customer, the cause of death was not clear- the patient was taken to the medical examiner to investigate.The patient also had a bleeding disorder, which the hospital thinks was the reason there was an issue with placing the line as this would be a contraindication.No other information available.Rate of death in resuscitated patients is usually high.In agreement with a customer, the patient's death was not related to the device or cooling procedure; it was related to the underlined clinical condition.
Event or Problem Description
A patient was hospitalized post cardiac arrest.The quattro catheter was inserted into a patient's femoral vein on (b)(6) 2018.The insertion was smooth.After insertion, blood was observed in the catheter lured tubing.Per clinical field specialist, the user was advised to replace the catheter over guidewire.Per updated information from clinical field specialist patient was declared deceased on (b)(6) 2018.Per reporter, patient was taken to the medical examiner to investigate.Patient also had a bleeding disorder which the hospital thinks was the reason there was an issue with placing the line as this would be a contraindication.Quattro catheter will not be returned back for evaluation.

• 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: 7356200
• Report Number: 3010617000-2018-00378
• Device Sequence Number: 1103433
• Product Code: NCX
• UDI-Device Identifier: 00849111075138
• UDI-Public: 00849111075138
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/20/2018

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 Model Number: IC-4593
• Device Catalogue Number: 8700-0660-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1