MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM QUATTRO 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	Patient Problem/Medical Problem (2688)
Date of Event	02/09/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The zoll catheter in complaint 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.
Event or Problem Description
A (b)(6) year old white male with an ohca secondary to ventricular fibrillation.Cooling was initiated and patient was enrolled into the study after informed consent was obtained.Zoll quattro ivtm catheter was inserted on right femoral vein on (b)(6) 2015 @ 1549.Cooling initiated at (b)(6) 2015 @1700, rewarming started (b)(6) 2015@ 1800, and normothermia was reached (b)(6) 2015 @13:00.Catheter was removed on (b)(6) 2015 @ 14:40h.The patient experienced an adverse event: ileus which began on (b)(6) 2015 @1015.The event was reported as not serious, not device or treatment related, and not anticipated complication.However, it was reported to be related to clinical condition.Event required treatment of manual disimpaction and administration of medication.Ileus was resolved with sequelae on (b)(6) 2015 @ 06:55.The investigator established that there was no relationship between the reported event with the device or procedure.The patient was discharged on docusate.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5693547
• Report Number: 3010617000-2016-00391
• Device Sequence Number: 291762
• Product Code: NCX
• UDI-Device Identifier: 00849111075121
• UDI-Public: 00849111075121
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2016

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: 05/05/2016
• Initial Report FDA Received Date: 06/01/2016
• 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: Other
• Patient Age: 72 YR