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

Model Number	IC-4593AE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The zoll catheter will not be returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed if the product is returned and investigation has been completed.There is no malfunction of the device nor is there any report of injury to the vessel.
Event or Problem Description
On (b)(6) 2016 at 5pm, a (b)(6) female patient weighing (b)(6), suffered a st-elevation myocardial infarction (stemi).The patient arrived at the hospital at 6:43pm via emergency medical services.The patient's temperature (at 7pm) prior to the ivtm therapy was 37.1°c.Anti-shivering medication was administered before cooling temperature management began.The thermogard console was set to a target temperature of 32°c.A zoll quattro catheter was inserted at 7:10pm, into the left femoral vein.Following the insertion of the catheter, it was reported that at 7:16pm, the patient experienced a ventricular fibrillation (vf).The patient received a shock and the event ended a minute later.The event was reported to have been resolved without sequelae.It was reported that it possible that the guidewire could have touched the right side of the patient's heart, contributing to the arrhythmia.It was also noted that the event could have been related to the patient's acute anterior stemi.At 9:04pm that evening, the patient reached target temperature.Catheter was removed on (b)(6) 2016, at 12:30pm.

• Brand Name: ZOLL IVTM XXXX CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 6091601
• Report Number: 3010617000-2016-00804
• Device Sequence Number: 1360102
• Product Code: NCX
• UDI-Device Identifier: 00849111075121
• UDI-Public: 00849111075121
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IC-4593AE
• Device Catalogue Number: 8700-0660-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2016
• Initial Report FDA Received Date: 11/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 46 YR
• Patient Weight: 65