MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) CARTO 3; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number D-1286-03-S

Device Problems Radio Signal Problem (1511); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Ventricular Fibrillation (2130)

Event Date 05/15/2017

Event Type  Injury  

Manufacturer Narrative

Event description continuation: at some point during the procedure, a clot was suspected, so coronary angiography was performed, which revealed no clots and no obstructions.It was noted that it was unknown precisely when vf occurred.It was determined that vf did not occur immediately upon signal loss, but was estimated to have occurred approximately 7-8 minutes later.Patient required extended hospitalization (a total of 2 nights) as a result of the adverse event for additional testing.Patient fully recovered with no residual effects.Medical history includes hiv.Physician¿s opinion regarding the cause of the adverse event is that it was related to a biosense webster, inc.Product malfunction.Physician indicated that there may be a correlation between the catheter failure and the ventricular fibrillation.Once the catheters entered the patient¿s body, they remained on the right side, as no transseptal puncture was performed.No ablation was performed during the procedure.It was noted that the catheter was unable to ablate as a result of a loss of energy.There is no further information regarding this issue.There were no errors reported on any biosense webster, inc.Equipment during the procedure.The study was not initialized, therefore, no force visualization, visitag parameters for stability, additional visitag filters, or color options were used.Since the patient's heart rhythm was not visible to the operator and the lack of monitoring of cardiac rhythm while devices are intracardiac might lead to undetected cardiac rhythm that can be life threatening, we are reporting this signal issue under both the c3 interface cable ¿ therapeutic and the thermocool smarttouch unidirectional catheter.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Concomitant products carto 3 system, model #: m-4800-01, serial #: (b)(4).Cool flow pump, model #: m-5491-01, serial #: (b)(4).Ep - shuttle rf generator system - 100w, model #: 39d-76x, serial #: (b)(4).Non-bwi products - st.Jude medical sl0 sheath (b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure for persistent atrial fibrillation with a thermocool smarttouch unidirectional catheter and a c3 interface cable ¿ therapeutic suffered ventricular fibrillation requiring electrical cardioversion and coronary angiography.During the procedure, the short introducers were placed.Coronary sinus (cs) catheter was positioned in the cs.Thermocool smarttouch unidirectional catheter was positioned on the ict (undefined).Per the physician, the thermocool smarttouch unidirectional catheter was not positioned on the his.Cs catheter and thermocool smarttouch unidirectional catheter were connected to the patient interface unit (piu).Immediately after connecting the catheters to the patient interface unit, body surface (bs) and intracardiac (ic) ecg signals were lost on the ep recording system.No ecg signal was available via the anesthesia machine.The carto 3 system was still in the initialization phase.No pacing channels could be selected.Set-up continued without ecg signals available.Connections between the ep recording system and the carto were checked.Carto, catheters, and cables were not suspected as being the source of the signal interference.The st.Jude medical sl0 sheath was placed.Capnometer measured carbon dioxide at zero, which triggered the alert for ventricular fibrillation.As a result, the external defibrillator was connected to the patient, vf was identified, and cardioversion was performed.Although cardioversion attempt # 1 was transiently successful, the patient resumed vf.Cardioversion attempt # 2 was successful.Cable was replaced and the ecg signal issue remained.Catheters were removed from the patient.Thermocool smarttouch unidirectional catheter and cable were disconnected and the ecg signals (unspecified) reappeared.

• Brand Name: CARTO 3
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6639175
• MDR Text Key: 77501263
• Report Number: 9673241-2017-00465
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: D-1286-03-S
• Device Catalogue Number: CR3434CT
• Device Lot Number: UNKNOWN_D-1286-03-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 51 YR