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

Model Number	8700-0660-01
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	01/23/2018
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.- attachment: [(b)(4)].
Event or Problem Description
A medwatch report mfr 2300320000-2018-8008 submitted by the facility on (b)(6) 2018 was received by zoll on 05 feb 2018 via postal mail.The report states the following: due to a suspected catheter leak the patient was inserted a new icy catheter (catheter # 2) to continue ivtm therapy (the previous report of suspected leak on the first icy catheter (catheter # 1) is referenced under (b)(4), mfr 3010617000-2018-00159).Approximately 3.5 hours after catheter placement, the saline bag was observed to be almost empty and a tinge of blood was observed on the start-up kit (suk) tubing, thus suspecting leak on the icy catheter.Ivtm therapy was discontinued.No known impact or patient consequence was reported.

• 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: 7284653
• Report Number: 3010617000-2018-00227
• Device Sequence Number: 16673297
• Product Code: NCX
• UDI-Device Identifier: 00849111075138
• UDI-Public: 00849111075138
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 02/20/2018

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: 8700-0660-01
• Device Catalogue Number: 8700-0660-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR