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

Model Number	IC-3893
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "suspected damaged balloon of the icy catheter (lot # 95028)" was not confirmed during the visual inspection and the functional testing of the returned catheter.No issues or discrepancies were found on the catheter.No device malfunction was observed during the testing, and the catheter functioned as intended.It is likely that the customer could have returned the wrong catheter for investigation.Visual examination of the returned catheter was performed.No physical damage was found on the catheter.The balloons were examined, and blood residues were observed on the balloons.No tears, balloon bond detachment, or rupture were noted.Functional pressure leak test of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.The catheter was connected to a pressurized inflation device, and the balloons were fully inflated when pressurized up to 100 psi, and no issues were observed.The balloons did not leak during inflation and deflation, and all lumens were flushed as intended.During further functional testing, the returned catheter was connected to a known good start-up kit (suk) and ran on a peristaltic pump for 10 minutes.No issues or leak were observed.Furthermore, the returned icy catheter was tested on a console system in both warming and cooling mode for a total of 2 hours.No leak was observed on the catheter, and the catheter performed as intended.Therefore, the reported complaint was not confirmed.
Event or Problem Description
While inserting the icy catheter (lot # 95028) into the patient's femoral vein to initiate the ivtm therapy, the user noted blood and saline diffused into the lumen of the catheter, and therefore, it was suspected that the balloon was damaged.As reported, the catheter was advancing smoothly with no unusual resistance when the issue occurred.The icy catheter was replaced, and the patient ivtm treatment was completed successfully with the same console.No consequences or impact to the patient.
Additional Manufacturer Narrative
B5 (describe event or problem) was updated based on the additional information received on 7/27/2020.
Event or Problem Description
To initiate the patient ivtm therapy, the user applied isodine solution to disinfect and prep the patient's skin for catheter insertion.The icy catheter (lot # 95028) insertion was proceeding smoothly with no unusual resistance into the patient's femoral vein; however, when the catheter was half-way inserted, the user noted blood and saline diffused into the lumen of the catheter.It was suspected that one of the catheter balloons was damaged.Subsequently, the icy catheter was replaced, and the patient ivtm treatment was completed successfully with the same console.No consequences or impact to the patient.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10324178
• Report Number: 3010617000-2020-00706
• Device Sequence Number: 11633932
• Product Code: NCX
• UDI-Device Identifier: 00849111075527
• UDI-Public: 00849111075527
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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-3893
• Device Catalogue Number: 8700-0782-03
• Device Lot Number: 95028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1