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

Model Number	IC-4593
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	06/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll has not yet received the zoll catheter for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.Medical safety assessment: event occurred when the patient was normothermic with ivt in place.When the customer did their daily awakening trial on sunday, the patient became highly agitated and thrashing around in bed.He got his legs up so high, that he snagged the tubing to the ivt and pulled the catheter out.After 2 more days of awakening and weaning trials, he was extubated and seemed neurologically intact.He subsequently moved out of icu.However, prior to pulling out the catheter on sunday, increased edema was noticed on l leg on saturday.The following day, an ultrasound showed a dvt.Pt was started on lovenox on (b)(6) and changed to eliquis on (b)(6).He was walking on the floor with pt today around 11, when a code blue was called for this patient.He was brought down to icu, tubed.We never got anything back except pea.Dr's are feeling maybe the patient had a pe.The patient clinical diagnosis that led to hospitalization and usage of ivtm is unknown.However, it was obviously a critically ill patient.Critically ill patients admitted to the icu are prone to thrombogenicity and 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.].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.Circulation aha.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.].Insertion site of catheter is unknown but presumably in l leg.In this case, dvt is possibly related to the quattro catheter due to relevant location.At the same time, the patient's clinical condition of critical illness made him predisposed to thrombogenicity and dvt, which is a common complication is such patients.Event is probably related to the patient's clinical condition as well.Event was serious because the patient has clinical symptoms and required treatment.Customer is queried for additional information.
Event or Problem Description
A patient was hospitalized and ivtm therapy was initiated utilizing quattro catheter.The patient was rewarmed and was being maintained at normothermia.When the customer did their daily awakening trial on sunday, (b)(6) 2018, the patient became highly agitated and thrashing around in bed.He got his legs up so high, that he snagged the tubing to the ivt and pulled the catheter out.After 2 more days of awakening and weaning trials, he was extubated and seemed neurologically intact.He subsequently moved out of icu.However, increased edema was noticed on the left leg on saturday, (b)(6) 2018, one day prior to pulling out the catheter on sunday.Following day, an ultrasound showed a dvt.The patient was prescribed an anticoagulant medication, lovenox on (b)(6) 2018 and changed to eliquis on (b)(6) 2018.The patient was noted walking on the hospital floor on (b)(6) 2018, around 11 am, when a code blue was called and the patient was brought down to icu intubated.The patient was in cardiac arrest and a dose of tpa was administered.Resuscitations continue for about 45 minutes, however, rosc (return of spontaneous circulation) was not achieved and the patient was pronounced dead.Per additional information received, an autopsy showed large saddle emboli.The patient had a medical history of drug abuse.

• 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: 7704424
• Report Number: 3010617000-2018-00741
• Device Sequence Number: 805324
• Product Code: NCX
• UDI-Device Identifier: 00849111075138
• UDI-Public: 00849111075138
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

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: IC-4593
• Device Catalogue Number: 8700-0660-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1