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	05/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter in complaint was returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
On (b)(6) 2018, the manufacturer was made aware of an event that occurred on (b)(6) 2016.Per information, the patient was inserted an icy catheter in the femoral vein with no reported issue.At an unspecified time during ivtm therapy, leak on the catheter was observed when contrast fluid was injected into one of the infusion lumens.Upon inspection, the median line of the catheter was observed to have split in half approximately 2 cm in length.The reporter was unable to specify the amount of pressure during contrast infusion.Following this, the catheter was removed and another catheter was placed to continue therapy with no further issue reported.No known impact or patient consequence was reported.No further information is available.
Additional Manufacturer Narrative
The reported catheter leak was confirmed.Visual examination found a tear on the medial luer due to mishandling.The catheter had blue in/out luers.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.The catheter was connected to a pressurized inflation device, the balloons fully inflated when pressurized up to 100 psi without any issues.The balloons did not leak during inflation and deflation.The customer used a pressurized infusion pump during therapy.The ifu warns against using pressurized device as it could damage the catheter.

• 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: 7423650
• Report Number: 3010617000-2018-00377
• Device Sequence Number: 1093673
• Product Code: NCX
• UDI-Device Identifier: 00849111075077
• UDI-Public: 00849111075077
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

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: 8700-0695-40
• Device Lot Number: 56934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1