MAUDE Adverse Event Report: ZOLL CIRCULATION INC. ICY INTRAVASCULAR HEAT EXCHANGE CATHETER KIT WITH CENTRAL VENOUS INFUSION CAPABI; SYSTEM, HYPOTHERMIA, INTRAVENOUS COOLING

Model Number	8700-0782-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Per physician's note: "the first icy catheter placed was defective with a blown balloon and had to be replaced over a wire.Unclear if fragments of the balloon were retained." catheter was saved and reported to the mfr.

• Brand Name: ICY INTRAVASCULAR HEAT EXCHANGE CATHETER KIT WITH CENTRAL VENOUS INFUSION CAPABI
• Common Device Name: SYSTEM, HYPOTHERMIA, INTRAVENOUS COOLING
• Manufacturer (Section D): ZOLL CIRCULATION INC. ; san jose CA 95131
• MDR Report Key: 8155091
• Report Number: MW5082037
• Device Sequence Number: 19425759
• Product Code: NCX
• UDI-Device Identifier: 00849111075237
• UDI-Public: (01)00849111075237(17)190523(10)
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/10/2018

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: 8700-0782-01
• Device Catalogue Number: 8700-0782-01
• Device Lot Number: 83342
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 52