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

Model Number	8700-0783-03
Medical Device Problem Codes	Leak/Splash (1354); Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2018
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
The patient was inserted a quattro catheter and received ivtm therapy.On day 2, the clinical engineer observed that the fluid level on the saline bag was low.Upon inspection, no signs of leak on the suk, thermogard console and on patient bedside was observed.No alarm on the console was observed.Blood on the catheter tubing was observed.A catheter leak is suspected.Ivtm therapy was discontinued.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
The reported event was confirmed during functional testing of the quattro catheter (lot# 77827).Visual inspection of the returned catheter was performed.No abnormalities with the catheter were seen.All lumens flushed as intended.During functional testing, the catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a pinhole leak was observed at the medial 1 balloon.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.Probable causes for the reported complaint can be a latent material defect.Historical complaints were reviewed for information related to the reported complaint and there was no previous history of complaint reported of the quattro catheter with lot# 77827.Correction for lot# 77827.

• Brand Name: IVTM QUATTRO CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 7535467
• Report Number: 3010617000-2018-00573
• Device Sequence Number: 13511104
• Product Code: NCX
• UDI-Device Identifier: 00849111050050
• UDI-Public: 00849111050050
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

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: 8700-0783-03
• Device Catalogue Number: 8700-0783-03
• Device Lot Number: 77827
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 59