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

Model Number	8700-0697
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no vessel injuries and no device malfunctions were reported.Per zoll labeling, possible complications with central venous catheters include thrombosis.Additionally, catheter related thrombosis are known complications with intravascular catheter use of any kind.Critically ill patients admitted to the icu are prone to dvt, mostly due to inflammatory status post injury, abnormal coagulation, immobilization and catheterization.Institutions should follow guidelines in dvt prevention which include pharmacological and mechanical methods.Insti¬tutional implementation of standard protocols that incorporate these measures may have contributed to the reduction of dvt rate.Importantly, therapeutic hypothermia using a zoll ivtm cooling catheter placed in the femoral vein is not as¬sociated with increased incidence of dvt or pe.The benefits of using ivtm in the critically ill patient population outweighs the potential risks of dvt and pe.The zoll catheter in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.The ccr will be re-opened if or when the product is returned and investigation has been complete.Device not returned.
Event or Problem Description
Customer reported that there has been three patients with deep vein thrombosis (dvts) and one patient with pulmonary embolisms (pe) using the zoll catheters.There was no patient information or event information provided.Zoll is in the process of obtaining additional information on the reported issues.For reference of related events: 3010617000-2016-00058, 3010617000-2016-00059, and 3010617000-2016-00060.

• Brand Name: ZOLL IVTM CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5371991
• Report Number: 3010617000-2016-00027
• Device Sequence Number: 568726
• Product Code: NCX
• UDI-Device Identifier: 00849111075114
• UDI-Public: 00849111075114
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Report Date (Section B): 01/14/2016

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: 8700-0697
• Device Catalogue Number: 8700-0697
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2016
• 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: Hospitalization; Other