MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number D-1183-20-S

Device Problem Noise, Audible (3273)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

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.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(4).Event description continuation: the power was not titrated.There were no error messages on biosense webster inc.Equipment during the procedure.

Event Description

It was reported that a (b)(6) male patient underwent an idiopathic ventricular tachycardia procedure for premature ventricular contractions originating in the right ventricular outflow tract with a navistar electrophysiology catheter and suffered a cardiac tamponade which required pericardiocentesis and surgical intervention.In addition, the patient suffered cardiac arrest, which required compressions and epinephrine.The patient is a dialysis patient.During the ablation phase, a pericardial effusion was noticed as the patient's blood pressure dropped.The effusion was confirmed by transthoracic echocardiogram.A pericardiocentesis was performed as well as a pericardial window.It was also reported that the patient coded twice, once during the procedure and a second time while in the emergency room.Chest compressions and epinephrine were administered to the patient.The patient was reported to be in stable condition following the event.The patient required extended hospitalization and was transferred to cedars sinai medical center because the other hospital did not have the ability to perform emergent ct surgery.The event was considered life threatening and the patient¿s condition has improved.The physician¿s opinion on the cause of the adverse event is that it was procedure related.Physician indicated after the events that he heard an audible steam pop at 57 seconds and that was the reason why he said to come off ablation.No transseptal puncture was performed.The patient did not receive anticoagulant during the procedure.The following sheaths were used during the procedure: terumo 6fr x 2, 7fr x 1, 8 fr x 1.The overall ablation time and last ablation cycle was 57 seconds.The generator was in temperature control mode.The temperature cutoff was 55°c, power cutoff was 50 watts.At the time of injury, the temperature was 55°c, impedance approximately 120 ohms, power 50 watts.

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6209883
• MDR Text Key: 63477345
• Report Number: 2029046-2016-00268
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990025
• 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: 12/02/2016

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
• Device Operator: Health Professional
• Device Model Number: D-1183-20-S
• Device Catalogue Number: NS7TCJL174HS
• Device Lot Number: UNKNOWN_D-1183-20-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 73