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

Model Number	IC-4593AE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis (2100); Patient Problem/Medical Problem (2688)
Date of Event	10/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter will not be returned for investigation.The customer has since discarded the product.Therefore, a physical investigation will not be performed.The patient was treated with cooling after cardiac arrest.Patients in post cardiac arrest condition are in high risk of development of dvt due to hemodynamic impairment and immobilize condition during hospitalization.Patient was started on 10.000 ie/ml heparin per day.4 days after the catheter was in place, ultrasound revealed a deep vein thrombosis in the inferior vena cava.The patient did not have any clinical symptoms.Dvt was treated with anticoagulation (lysis).The patient's condition is reported to be good.Dvt is a known complication of any central line usage, especially after several days.Even the patient was predisposed for dvt.There was no vessel injuries and no device malfunctions were reported.Per zoll labeling, possible complications with central venous catheters include thrombosis.
Event or Problem Description
A (b)(6) year old male patient weighing (b)(6) underwent treatment for hypothermia after a cardiac arrest.The patient's temperature prior to the ivtm therapy was 36.3 deg c.The thermogard console was set to a target temperature of 33 deg c no other adjunctive temperature management procedures were performed on the patient.There was no separate catheter used for the central line.Patient was started on 10.000 ie/ml heparin per day.A zoll quattro catheter was inserted into the right femoral vein on an unspecified date.Catheter insertion was smooth and was performed in one attempt.The warming rate was set to 0.15 deg c and the patient was being warmed from 36 deg c.The ivtm console ran in the warming mode for 24 hours.During patient's temperature management therapy, there were no system alarms noted and no leaks observed.The dwell time of the catheter was 4 days and was not replaced.During an ultrasound (date not specified) a deep vein thrombosis (dvt) was observed in the inferior vena cava.The patient was not in a high risk for dvt.The patient was treated with anticoagulation (lysis).No other adjunct procedures were performed on the patient.There were no vessel injuries caused by the zoll catheter.It is unknown if the reported thrombus was attributable to the zoll device.The patient's current condition is reported to be good.

• 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: 6097825
• Report Number: 3010617000-2016-00809
• Device Sequence Number: 1124039
• Product Code: NCX
• UDI-Device Identifier: 00849111075121
• UDI-Public: 00849111075121
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IC-4593AE
• Device Catalogue Number: 8700-0660-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2016
• Initial Report FDA Received Date: 11/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 40 YR
• Patient Weight: 85