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

Model Number	IC-4593AE
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
A (b)(6) years old female patient weighing (b)(6) kg and 165 cm in height was hospitalized post cardiac arrest and underwent treatment for hypothermia.A zoll catheter was inserted by an experienced inserting practitioner.Catheter insertion was smooth.The in dwell time of the catheter was approximately one hour.Bair hugger adjunctive temperature management procedure was used.Hematoma was noted before the temperature treatment was initiated.After the quattro catheter was removed, the puncture site was manually compressed.Nevertheless, a hand- sized hematoma developed.The temperature treatment was never started.The catheter was not replaced.The patient is now being treated in an intensive care unit (icu).No other information was provided.
Additional Manufacturer Narrative
Evaluation of the returned quattro catheter revealed no issues with the catheter.The catheter functioned as intended.A visual inspection of the returned catheter was performed.The quattro catheter was received with a guidewire that was inserted through the distal luer.The distal balloon was also noted to be kinked.All lumens flushed as intended.During functional testing, the catheter was connected to a pressurized inflation device.Capping the "out" luer and connecting the "in" luer to the pressure inflation device.The catheter was pressurized up to 100 psi and the pressure was observed for one minute without any leak.Following the test, all balloons deflated successfully without any issues.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of related complaints for quattro catheter (b)(4).No intervention was performed due to this event.Access site hematoma is a known event in use of any vascular 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: 6298865
• Report Number: 3010617000-2017-00074
• Device Sequence Number: 603636
• 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,Followup
• Report Date (Section B): 03/28/2017

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: 57438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 79