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

Catalog Number	8700-0660-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Thrombosis (2100)
Date of Event	03/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
On (b)(6) at 09:36, a (b)(6) male lost consciousness and went into cardiac arrest during exercise activity.Bystander cpr and aed were administered while waiting for the emergency response team.During transport to hospital, the patient's circulation returned, but patient's state of consciousness was poor.The patient was then transferred to (b)(6) and was admitted at 16:28.The patient's gcs at the time of hospitalization was 1-1-4 as an unspecified sedative agent was administered at the previous hospital.At 17:25, a zoll quattro catheter was inserted in the patient and the hypothermia treatment was started.Target temperature was set at 34 degree celsius and rewarming at target temperature of 1 degree celsius per day.No anticoagulation treatment was given due to patient's hemorrhagic tendency (aptt at 53 seconds).On (b)(6), ivtm treatment ended as scheduled.On (b)(6) at 12:00, fever was observed and infection was suspected.The patient's blood and the quattro catheter were tested.Results showed gram-positive (+) cocci detected.Antibiotics were administered.On (b)(6), echocardiographic examination was performed.A case of inferior vena cava thrombosis was confirmed and the patient was treated with continuous infusion of heparin from (b)(6).The physician stated that the patient had an underlying disease, hypertrophic cardiomyopathy, and therefore, is normally expected to have a thrombotic tendency.The patient suffered shock liver and consequently, had a hemorrhagic tendency when the hypothermia treatment began.The patient developed infection (bacteremia) and the patient's thrombotic tendency increased as a result.The patient recovered from both infection and inferior vena cava thrombosis.
Additional Manufacturer Narrative
Critically ill patients admitted to the icu are prone to dvt, mostly due to inflammatory status post injury, abnormal coagulation, immobilization and catheterization.Institutions should follow guidelines in dvt prevention which include pharmacological and mechanical methods.[zoller b, li x, sundquist j, et al.Risk of pulmonary embolism in patients with autoimmune disorders: a nationwide follow-up study from sweden.Lancet.2012;379:244-249.].According to the physicians, the patient had an underlying disease, hypertrophic cardiomyopathy, and therefore, is normally expected to have a thrombotic tendency.The patient suffered shock liver and consequently, had a hemorrhagic tendency with aptt 53 sec at the time treatment began.The d-dimer value was 3.74 at the start of treatment and rose to 8.19 at the time treatment ended.The patient is young and suffered a cardiac arrest during athletic activity.Institutional implementation of standard protocols that incorporate these measures may have contributed to the reduction of dvt rate.Importantly, therapeutic hypothermia using a zoll ivtm cooling catheter placed in the femoral vein is not associated with increased incidence of dvt.Four randomized controlled clinical trials (2 multicenter and 2 single center trials) conducted in a total of 943 patients showed that there was no difference in the dvt rate when comparing zoll ivtm catheters to standard cvcs.[deye n, cariou a, girardie p, et al.Endovascular versus external targeted temperature management for out-of-hospital cardiac arrest patients: a randomized controlled study.Circulationaha.114.012805.Published online before print june 19, 2015, doi: 10.1161/circulationaha.114.012805; diringer mn, et al: treatment of fever in the neurologic intensive care unit with a catheter based heat exchange system.Crit care med 2004 vol.32, no.2; white paper edc-2888.].The patient had a serious case of myocardial hypertrophy as an underlying disease and a risk of thrombosis was believed to be high.The patient developed infection (bacteremia) and the physician thinks that a thrombotic tendency increased as a result.According to physicians comment, normally, an ivtm catheter is inserted when angiogram is performed.Therefore it is inserted in a clean environment.In this case, however, the patient had been transferred from another hospital and an ivtm catheter was inserted immediately in the er.It is believed that the patient contracted an infection at that time.Also, the catheter was in place for 5 days but approved dwell time is 4 days only.This extended use could predispose the pt to infection and thromboses.Institutions should follow centers for disease control and prevention (cdc) recommendations, which include strict hand hygiene, using maximum barrier precautions during catheter insertions, skin cleansing with chlorhexidene, and prompt removal of the catheter after use.Institutional implementation of standard protocols that incorporate these measures may have contributed to the recently observed reduced incidence of central line-associated bloodstream infection (clabsi) overall.[o'grady alexander, m, burns la, et al: cdc guidelines for the prevention of intravascular catheter-related infections.Centers for disease control and prevention.Available at: http://www.Cdc.Gov/hicpac/bsl/bslguidelines- 2011.Html 2011 accessed september 29, 2011.].Event was serious due to central location of thrombus event in patient who did not experienced any clinical symptoms of thrombosis.Event was not related to zoll device or procedure and related to the patient's clinical condition and treatment at the hospital.

• 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: 6490830
• Report Number: 3010617000-2017-00287
• Device Sequence Number: 11025088
• Product Code: NCX
• UDI-Device Identifier: 00849111050050
• UDI-Public: 00849111050050
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2017

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 Catalogue Number: 8700-0660-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 05/30/2017
• 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