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

Model Number	IC-3893AE
Medical Device Problem Codes	Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed during functional testing of the returned icy catheter (lot # 74927).Visual inspection of the catheter upon receipt found no physical damage.The distal lumen could not flush, whereas medial and proximal lumen flushed.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.During functional testing, the catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a bond leak was observed on the distal balloon.During manufacturing all icy catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Probable causes for the reported complaint can be a latent material defect.Historical complaints were reviewed for information related to the reported complaint and ccr (b)(4) was reported for the icy catheter with lot # 74927 on (b)(6) 2018 for bond leak on the distal balloon.
Event or Problem Description
At an unspecified time during ivtm therapy, the thermogard console displayed an airtrap alarm and a check saline alarm.The user observed that the saline bag was empty.Upon further inspection no sign of leak on the suk, or on the patient bedside was reported.Catheter leak was suspected.Following this, the user discontinued ivtm therapy and removed the catheter.No known impact or patient consequence was reported.No further information provided.Mfr 3010617000-2018-00654 for thermogard console.

• 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: 7602583
• Report Number: 3010617000-2018-00607
• Device Sequence Number: 19181379
• Product Code: NCX
• UDI-Device Identifier: 00849111075107
• UDI-Public: 00849111075107
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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-3893AE
• Device Catalogue Number: 8700-06957-40
• Device Lot Number: 74927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1