MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D-1282-07-S

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Atrial Fibrillation (1729); Ventricular Fibrillation (2130)

Event Date 03/10/2017

Event Type  Injury  

Manufacturer Narrative

Connected to the carto prior to connecting the soundstar eco catheter.The soundstar eco catheter was connected to both the carto and the ultrasound system when the issue occurred.Cartosound/uls was selected on carto system.Name of ultrasound system selected on the carto system was sc2000.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: thermocool smarttouch bi-directional navigation catheter, model #: d-1327-04-s, lot #: 17625794m.Soundstar eco catheter, model #: m-5723-15, lot #: e5028907.Stockert 70 system, model #: m-5463-01, serial #: (b)(4).Coolflow pump, model #: m-5491-02, serial #: (b)(4).Carto 3 system, model #: m-4800-01, serial #: (b)(4).Brand-unspecified products: sc2000 ultrasound system (21/403185).(b)(4).

Event Description

It was reported that a female patient underwent an ablation procedure for atrial fibrillation under general anesthesia with a pentaray navigational eco catheter and suffered ventricular fibrillation requiring defibrillation.During the mapping phase with the pentaray navigational eco catheter, the patient went into ventricular fibrillation.Defibrillation converted the patient to normal sinus rhythm.Remainder of procedure was aborted.It was noted that the patient was initially in atrial fibrillation with a prolonged qt interval secondary to a medication.Physician wanted to postpone the procedure until the medication was fully metabolized and the qt interval returned to normal.Patient was on inpatient status prior to the procedure.Patient required hospitalization over the weekend to confirm that medications fully metabolized and the prolonged qt interval remained normalized.Patient fully recovered.Physician¿s opinion regarding the cause of the adverse event is that it was related to patient condition.Physician indicated that the prolonged qt interval was a result of medication that the patient received.Transseptal puncture was performed with an unspecified needle.It was noted that the patient was under general anesthesia for approximately 2 hours prior to aborting the procedure.The smarttouch bidirectional catheter was plugged into the patient interface unit, but was not placed in the patient¿s body.No ablation was performed.Physician does not consider that aborting the procedure may have caused or contributed to a death or a serious injury to the patient.It was also reported that a not reportable catheter sensor error 6150 displayed on the carto 3 system.The soundstar eco catheter was replaced and the issue resolved.The mapping catheter was not.

• Brand Name: PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 6465376
• MDR Text Key: 72065647
• Report Number: 9673241-2017-00263
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: D-1282-07-S
• Device Catalogue Number: D128207
• Device Lot Number: 17558840L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention