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

Model Number	CL-2295AE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Shock (2072)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The zoll catheter was not returned for investigation.Therefore, a physical investigation could not be performed.A supplemental report will be filed if the product is returned and investigation has been completed.Medical safety assessments: this assessment is for reported in the article one event of hemorrhagic shock in the patient.Article by olivier andremont, et al."endovascular cooling versus standard femoral catheters and intravascular complications: a propensity-matched cohort study," reported that four (4) patients in the targeted temperature management (ttm) group presented major complications".This report is 1 of 4.As stated in the article, all patients were admitted to an intensive care unit for successfully resuscitated cardiac arrest.The femoral site was used for insertion of all cooling catheters.On an unspecified date between (b)(6) 2012 and (b)(6) 2014, "haemorrhagic shock complicated catheter insertion (grade 4)".There is no other information about incident of hemorrhagic shock provided in the article.Statistical data is available for treatment group as a whole: management of target temperature of 33-34°c was induced and maintained for 12-24 h.In the article, physician indicated that the catheterization time was longer than recommended for the ttm period for coolgard catheter but this information is a statistical data for all patients in a cooling group, not information about this specific patient.Hemorrhagic shock is a condition of reduced tissue perfusion, resulting in the inadequate delivery of oxygen and nutrients that are necessary for cellular function.The severity of hemorrhagic shock can be graded on a 1-4 scale on the physical signs.This approximates to the effective loss of blood volume.Class iv hemorrhage as reported in the article, is a severe blood loss.There is no information about patient's clinical condition that led to cardiogenic shock and a history of the type, amount, and duration of bleeding.Based on limited information about this event such as statement that "hemorrhagic shock complicated the catheter insertion", and the fact that "catheterization time was longer than recommended", event assessed as possibly related to the catheter.Event is anticipated because bleeding complications can occur with usage of any catheter.Event assessed as serious due to reported grade 4.
Event or Problem Description
It was reported in the journal article "endovascular cooling versus standard femoral catheters and intravascular complications: a propensity-matched cohort study," that four (4) patients in the targeted temperature management (ttm) group presented major complications.This report is 1 of 4.On an unspecified date between (b)(6) 2012 and (b)(6) 2014, a coolgard catheter was placed in patient's femoral vein.Haemorrhagic shock complicated the catheter insertion.The catheter dwell time was 4.2 days.In the clinical study, the physician indicated that the catherterization time was longer than recommended for the ttm period for coolgard catheter.The specific catheter used in the study has not been reported to zoll.As default, the cool line catheter was selected.Patient 2 of 4 (ccr 38934)- mfr 3010617000-2018-00180, patient 3 of 4 (ccr 38935)- mfr 3010617000-2018-00181, patient 4 of 4 (ccr 38936)- mfr 3010617000-2018-00182.

• Brand Name: ZOLL IVTM COOL LINE CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7277443
• Report Number: 3010617000-2018-00176
• Device Sequence Number: 2006567
• Product Code: NCX
• UDI-Device Identifier: 00849111075039
• UDI-Public: 00849111075039
• 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: foreign,health professional,l
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

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: CL-2295AE
• Device Catalogue Number: 8700-0696-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/16/2018
• 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