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

Model Number	IC-4593
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of difficulty in advancing the quattro catheter (lot 195901) over the guidewire (lot 195901) was confirmed during visual inspection.The catheter was returned with the guidewire stuck inside the catheter.The root cause of the reported complaint was due to the kinked guidewire, likely attributed to a handling issue and/or insertion of the guidewire.No malfunction was observed on the catheter.Visual inspection of the returned catheter was performed.As returned, the guidewire was stuck inside the catheter.The guidewire was able to be removed from the catheter with resistance due to the kinks on the guidewire.No physical damage was observed on the catheter.Blood residue was observed on the balloons and luered tubings.Functional testing of the returned catheter was performed.All infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to a pressurized inflation device, and the balloons were fully inflated when pressurized up to 100 psi.No leak was observed, and the catheter functioned as intended.An additional guidewire test was performed.A known-good zoll guidewire was slowly inserted through the central lumen of the catheter starting at the catheter tip and exited through the distal infusion luer port without resistance.The guidewire could be passed through the entire length of the lumen with no resistance.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaints reported for the quattro catheter with lot 195901.
Event or Problem Description
The customer reported difficulty in advancing the quattro catheter (lot 195901) over the guidewire (lot 195901) during placement by an emergency department (ed) resident.The patient had normal anatomy.The customer did not report any resistance with guidewire insertion.The customer reported the resident was pushing way harder than she should have to get catheter into the vessel.The guidewire was confirmed to be in the correct position in the vessel and catheter insertion was initially very smooth until the catheter was about ¾ of the way inserted, then resistance was felt.The resident tried to remove the guidewire, but it was snagged on something, and resistance was felt during the attempt to remove the guidewire.Instead of removing the entire catheter and guidewire together, she pulled harder on the guidewire, and it unraveled.She then removed both the entire catheter and guidewire simultaneously without issue, and it was all intact.No additional intervention was required.No kinks were observed on the guidewire prior to or after the removal.A new catheter was placed without issue.No impact or consequence to the patient.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19294458
• Report Number: 3010617000-2024-00389
• Device Sequence Number: 7130681
• Product Code: NCX
• UDI-Device Identifier: 00849111075282
• UDI-Public: 00849111075282
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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-4593
• Device Catalogue Number: 8700-0783-01
• Device Lot Number: 195901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown