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

Model Number	IC-4593AE
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the 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 patient who suffered a fall was life-flighted to a hospital for the resultant epidural and subdural hematoma.In the hospital, the patient received ivtm therapy.A quattro catheter (lot # unknown) was inserted into the patient's left femoral vein in 2 attempts with no immediate complications.At the time of the catheter placement, the patient had a left radial arterial line for blood pressure (bp) monitoring.During the cooling phase of the treatment, after about 45 minutes of operation, the thermogard console displayed an alarm of type not reported by the user.Subsequently, it was noted that fluid within the out luer tubing of the start-up kit (suk) had a reddish tinge (blood), indicating a potential catheter leak.Furthermore, it was observed that the 500-ml bag of saline supply was nearly empty and contained serosanguinous fluid.There were no traces of saline observed on the floor, patient's bed, or on the console.The quantity of saline possibly infused into the patient's bloodstream was unknown.Treatment was paused to remove the quattro catheter, and a second catheter (solex) was successfully inserted into the patient's left jugular vein.The treatment continued and was completed successfully using the same ivtm console.No consequences or impact to patient.
Additional Manufacturer Narrative
The reported complaint of "leak from the quattro catheter (lot # 144296)" was confirmed during functional testing of the returned catheter.A pinhole leak was observed in the distal end of the distal balloon during the functional pressure leak test.The probable root cause of the pinhole leak was a latent material defect.Visual examination of the returned catheter was performed, and no physical damage was found on the catheter.It was noted that blood had accumulated/dried up on the suture tab.Dried blood residues were also observed in the balloons and inside of all the luered tubings.Functional leak test of the returned catheter was performed, and all infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to a pressurized inflation device for one minute, and the balloons were fully inflated when pressurized up to 100 psi.Immediately upon pressurizing the catheter, a pinhole leak was observed at the distal end of the distal balloon; thus, confirming the reported complaint.It is unlikely that the defective catheter was shipped.During manufacturing, all catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaints reported for quattro catheter with lot number 144296.
Event or Problem Description
A patient who suffered a fall was life-flighted to a hospital for the resultant epidural and subdural hematoma.In the hospital, the patient received ivtm therapy.A quattro catheter (lot # 144296) was inserted into the patient's left femoral vein in 2 attempts with no immediate complications.At the time of the catheter placement, the patient had a left radial arterial line for blood pressure (bp) monitoring.During the cooling phase of the treatment, after about 45 minutes of operation, the thermogard console displayed an alarm of type not reported by the user.Subsequently, it was noted that fluid within the out luer tubing of the start-up kit (suk) had a reddish tinge (blood), indicating a potential catheter leak.Furthermore, it was observed that the 500-ml bag of saline supply was nearly empty and contained serosanguinous fluid.There were no traces of saline observed on the floor, patient's bed, or on the console.The quantity of saline possibly infused into the patient's bloodstream was unknown.Treatment was paused to remove the quattro catheter, and a second catheter (solex) was successfully inserted into the patient's left jugular vein.The treatment continued and was completed successfully using the same ivtm console.No consequences or impact to patient.

• 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: 12029638
• Report Number: 3010617000-2021-00522
• Device Sequence Number: 4269268
• Product Code: NCX
• UDI-Device Identifier: 00849111075138
• UDI-Public: 00849111075138
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2021

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: 8700-0660-01
• Device Lot Number: 144296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 06/19/2021
• Supplement Report FDA Received Date: 07/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1