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

Model Number	IC-4593
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The quattro catheter associated with this complaint was discarded by the customer.Since the device was not returned, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
The customer called the zoll ivtm tech support customer service line and asked how to properly remove the quattro catheter (lot # unknown), as they were experiencing resistance during removal.The customer was instructed to deflate the catheter balloons by removing all the saline from the catheter using the slip-tip syringe and attaching it to the in luer while having the out luer clamped before applying the vacuum from the syringe.After ensuring that the nurse was only pulling saline and leaving the other luers open to the air, the customer experienced resistance while trying to remove the catheter.The customer attempted turning the catheter while pulling back yet still experienced resistance.There was no occlusion (e.G., ivc filter, implant, or another device planted in the same vein) or increased tortuosity in the patient's vein.Zoll clinical territory associate recommended the customer remove the catheter under fluoroscopy if resistance is met and if unable to remove the catheter manually.The vascular surgery team consulted the issue, but no surgical intervention was needed.The customer put a guidewire back through the catheter to straighten it out.The catheter was removed at the bedside without harming the patient.The catheter functioned as intended throughout the ivtm therapy, and the ivtm therapy was completed, but the dwell time of the catheter is unknown.No consequences or impacts on the 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
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19327175
• Report Number: 3010617000-2024-00393
• Device Sequence Number: 6816100
• Product Code: NCX
• UDI-Device Identifier: 00849111075282
• UDI-Public: 00849111075282
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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