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

Model Number	IC-3893
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	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll icy catheter was not returned to zoll for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
The customer reported that during ivtm therapy the icy catheter (lot # unknown) was placed in the patient's vein.The catheter location was not specified by the reporter.A catheter leak was suspected.The patient treatment was stopped after removing the catheter, however, the specifics of the alternative therapy were not disclosed.No additional information was provided.No consequences or impact to the patient.
Additional Manufacturer Narrative
The reported complaint of the icy catheter (lot # 158738) leak was confirmed during the functional testing.A leak was observed at the distal end of the distal balloon during in/out luers flushing.The root cause for the reported complaint resulted from a circumferential tear, which was possibly caused by a latent material defect.Upon visual inspection, the distal luered tubing was noted completely cut off by the user (1cm away from the proximal end of the manifold), the catheter was returned without a distal infusion luer.Noticed a blood residue on the catheter's balloons and in luered tubings.In addition, the catheter shaft was observed kinked at 7.5 inches away from the catheter tip.Most likely, that the catheter was damaged when it was folded and placed into the bag for shipping.During functional testing, all infusion ports and extension tubes were flushed without resistance except distal luered tubing as tubing was cut.During in/out lumen test, a leak was observed at the distal end of the distal balloon.When observed under the microscope, a circumferential tear was noted on the balloon.Unable to perform the pressurized functional testing due to the condition in which the catheter was received.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 service information related to the reported complaint, and there was no previous history of complaint reported for the icy catheter with lot number 158738.Additional information in b5, d4, and h4.
Event or Problem Description
The customer reported that during ivtm therapy the icy catheter (lot # 158738) was placed in the patient's vein.The catheter location was not specified by the reporter.A catheter leak was suspected.The patient treatment was stopped after removing the catheter, however, the specifics of the alternative therapy were not disclosed.No additional information was provided.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 95131
• MDR Report Key: 12292040
• Report Number: 3010617000-2021-00746
• Device Sequence Number: 11722192
• Product Code: NCX
• UDI-Device Identifier: 00849111075237
• UDI-Public: 00849111075237
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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-3893
• Device Catalogue Number: 8700-0782-01
• Device Lot Number: 158738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR