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

Model Number	IC-4593AE
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported complaint of the quattro catheter might have a crinkle was not confirmed.Evaluation of the returned quattro catheter revealed no issues with the catheter.The catheter functioned as intended.During functional testing, the returned catheter was connected to a pressurized inflation device and pressure was increased up to 100psi.No leaks were observed.No issues found during catheter deflation.No crinkle was noted.Visual inspection found no visual discrepancies or issues.All lumens flushed as intended.No leaks were noticed during flushing.No cracks were observed.No abnormalities with the catheter was seen which may have contributed to the reported complaint.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of related complaints for quattro catheter sn (b)(4).
Event or Problem Description
A patient was hospitalized and underwent treatment for hypothermia.The patient's temperature prior to the ivtm therapy was 36.0 degree celsius.The thermogard console was set to a target temperature of 33.0 degree celsius.No other adjunctive temperature management procedures were performed on the patient.A zoll quattro catheter was inserted into the left femoral vein by a physician.The catheter insertion was smooth.The in dwell time of the catheter was 24 hours.At an unspecified time during hypothermal therapy, the reporter indicated the patient warmed up; however, the cooling phase was not noted.The attending health care professional (hcp) noted a flow disturbance within the catheter.A crinkle in the catheter was suspected.The customer tried to aspirate the catheter using a syringe; however, was unsuccessful.Without the flow the patient could not be cooled, therefore, the catheter was replaced on (b)(6) 2017.There was no reports of an adverse event as a result of the reported issue.The patient remains stable.

• Brand Name: ZOLL IVTM XXX CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 6327822
• Report Number: 3010617000-2017-00122
• Device Sequence Number: 769010
• 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: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2017

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: IC-4593AE
• Device Catalogue Number: 8700-0660-40
• Device Lot Number: 66331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2017
• Initial Report FDA Received Date: 02/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1