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

Model Number	8700-0657
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during patient use the quattro catheter may have a leak.The patient was admitted to the emergency room (er).Ivtm (intravenous temperature management) therapy was started.A quattro catheter was inserted into the patient.The insertion was smooth, without issue.Shortly after the treatment started the er staff noticed that 1.5 liters of saline was gone from the saline bag.There was no fluid on the floor or under the patient.No patient sequelae was reported.No additional information was provided.Note: the infusion of a 500 ml bag of saline into a patient would not present a serious injury to a person with functioning fluid balance physiology.The response would be the loss of the fluid via increased urine output.
Event or Problem Description
It was reported that during patient use the quattro catheter may have a leak.The patient was admitted to the emergency room (er).Ivtm (intravenous temperature management) therapy was started.A quattro catheter was inserted into the patient.The insertion was smooth, without issue.Shortly after the treatment started the er staff noticed that 1.5 liters of saline was gone from the saline bag.There was no fluid on the floor or under the patient.No patient sequelae was reported.No additional information was provided.
Additional Manufacturer Narrative
An icy catheter was returned to zoll (b)(4) for evaluation.A visual inspection found no visual discrepancies or issues.All lumens flushed as intended.No leaks were noticed during flushing.The returned catheter was connected to a pressurized inflation device.When the catheter was pressurized up to 40 psi, and a leak was noted on the distal balloon.A cut was noted on the balloon.Evaluation of the returned devices confirmed the customer reported issue as an icy catheter leaked at the distal balloon.The probable cause for the customer reported issue was due to user mishandling, including, but not limited to damage during device operation.There was no patient injury or death attributable to the catheter.
Additional Manufacturer Narrative
An icy catheter was returned to zoll (b)(4) for evaluation.A visual inspection found no visual discrepancies or issues.All lumens flushed as intended.No leaks were noticed during flushing.The returned catheter was connected to a pressurized inflation device.When the catheter was pressurized up to 40 psi, and a leak was noted on the distal balloon.A cut was noted on the balloon.Evaluation of the returned devices confirmed the customer reported issue as an icy catheter leaked at the distal balloon.The probable cause for the customer reported issue was due to user mishandling, including, but not limited to damage during device operation.There was no patient injury or death attributable to the catheter.

• 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: 5638906
• Report Number: 3010617000-2016-00312
• Device Sequence Number: 880213
• Product Code: NCX
• UDI-Device Identifier: 00849111075121
• UDI-Public: 00849111075121
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2016

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: 8700-0657
• Device Catalogue Number: 8700-0657-01
• Device Lot Number: 58851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/11/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/06/2016
• Supplement Report FDA Received Date: 06/23/2016; 06/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1