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

Catalog Number	8700-0660-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter in complaint was returned to zoll for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
A patient was hospitalized post cardiac arrest and underwent treatment for hypothermia.A zoll icy catheter was inserted.The in dwell time of the catheter was 36 hours.During warming phase, the system alarmed "low airtrap fluid ".The saline bag had run dry.The catheter was removed and no blood tinge observed.Surface intervention was used to continue and complete the treatment.No known patient consequences was reported.
Additional Manufacturer Narrative
The customer's reported complaint was not confirmed during functional testing.Evaluation of the returned icy catheter indicated that the catheter performed as per specifications.Functional test of returned catheter was performed.All infusion ports were flushed without any issues.The catheter was connected to a pressurized inflation device; the balloons fully inflated when pressurized up to 100 psi and the balloons did not leak during inflation and deflation.Further investigation, the units (returned icy catheter and in-house test suk) was connected to an ivtm system and ran on max cooling and max warming for approximately 30 minutes each run; no leaks were observed.A visual inspection of the returned catheter was performed.Blood had accumulated /dried up on the balloons, shaft, luered tubing's and infusion ports.The balloons were examined and there were no tears, balloon bond detachment or rupture noted.Note, during manufacturing, all icy catheters are 100% inspected for leaks.In addition, extension tubing is 100% tested for leaks.Only units that passed are moved to the next process.Historical complaints were reviewed and one previous related complaint ((b)(4)) was reported on 11/17/2016 for icy catheter (lot# 64907) with the same issue catheter leaks.However, leaks were not observed during evaluation.

• Brand Name: ZOLL IVTM XXX CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 6348103
• Report Number: 3010617000-2017-00142
• Device Sequence Number: 720115
• Product Code: NCX
• UDI-Device Identifier: 00849111075077
• UDI-Public: 00849111075077
• 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,Followup
• Report Date (Section B): 03/10/2017

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 Catalogue Number: 8700-0660-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 03/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1