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

Model Number	SL-2593
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed if the product is returned and investigation has been completed.A potential causal relationship between a patient injury and the use of a device cannot be established based on available information.There is no information fo rteh location and timing of the event as related to the use of the device.
Event or Problem Description
On an unspecified date, a solex catheter was used in a patient' temperature management therapy.During therapy, it was reported that the patient developed a large hematoma; however, it is not known if the issue was a result of the actual insertion of the catheter.No further patient information was provided.There is no known patient consequence or impact reported.

• Brand Name: ZOLL IVTM SOLEX CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 6248346
• Report Number: 3010617000-2017-00035
• Device Sequence Number: 763301
• Product Code: NCX
• UDI-Device Identifier: 00849111075152
• UDI-Public: 00849111075152
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2017

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: SL-2593
• Device Catalogue Number: 8700-0671-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2016
• Initial Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1