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

Model Number	SL-2593
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	10/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
A medwatch report (no reference number) was received by the manufacturer via postal mail on 04 dec 2017.The reported event states a suspected leak on the inserted cool line catheter (lot 63082).Per report, ruptured balloon and blood on the catheter tubing were observed.No known impact or patient consequence was reported.No further information was provided.
Additional Manufacturer Narrative
Section : updated to reflect information regarding the received solex catheter the coolline catheter (lot 63082), as documented in the received medwatch report, was not returned.Instead, a solex catheter (lot 63082) was received by the manufacturer for evaluation.Visual inspection of the catheter upon receipt indicated evidence of accumulated dried blood on the catheter balloons, although this was observed inspection found all the catheter balloons to be intact.Further examination also revealed dried blood inside the "in" luer tubing.The tubing was clogged, due to this observed condition, a catheter pressurization test through the "in" luer was not possible.The catheter infusion ports were tested.The proximal, medial, and distal lumens all flushed as intended.In addition, a lumen crosstalk test was performed, by capping the "out" luer and connecting the pressure inflation device to the proximal, medial, and distal luers.The catheter was pressurized and no leak was noted with all the three lumens.The report of leak could not be conclusively determined though this evaluation.The secondary report of balloon rupture was not confirmed.No tear, balloon bond detachment, or balloon rupture was observed during visual inspection and functional testing of the catheter.During manufacturing all solex catheters are 100% inspected for leaks including the integrity of the balloons by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed for information related to the reported complaint and no similar complaint was reported for the solex catheter with lot # 63082.

• 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: 7105668
• Report Number: 3010617000-2017-01104
• Device Sequence Number: 16339025
• Product Code: NCX
• UDI-Device Identifier: 00849111075046
• UDI-Public: 00849111075046
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 02/28/2018

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: SL-2593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: 63082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 65