MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number M-5723-17

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226)

Event Date 05/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a soundstar® eco diagnostic ultrasound catheter and suffered a cardiac tamponade and cardiac arrest which required pericardiocentesis and surgical intervention.When the soundstar eco catheter was connected, a non mdr reportable magnetic sensor error occurred.The issue was resolved by changing the catheter to another one.A soundstar merge was then done and a transseptal puncture was performed.The replacement soundstar eco catheter was then inserted into the right ventricle (rv) for monitoring effusions.Right after the pulmonary vein isolation (pvi) was started, the patient¿s blood pressure dropped and a cardiac tamponade was confirmed.A pericardiocentesis was conducted and an unknown amount of fluid was removed.The patient became stable after a few hours and the pvi was re-conducted but the patient¿s blood pressure dropped again.Another pericardiocentesis was performed which was not successful and the patient was taken for surgery.Cardiac arrest occurred after surgery and at that time the patient was unstable.The patient did require hospitalization due to the condition worsening.The patient has since fully recovered.The physician¿s opinion regarding the cause of this adverse event is that this is procedure related.The physician commented the adverse event might have been caused by the transseptal needle (brand unknown) during the transseptal phase or by the second soundstar eco catheter that was inserted into the rv.Generator settings include: power control mode.There were no error messages observed on biosense webster equipment during the procedure.This event is usually reported under the ablation catheter, however since the physician believes this catheter was the possible causative device it is only being reported under this soundstar catheter.

Manufacturer Narrative

Additional information was received on this product on 06/27/2016.The manufacturing date is 02/11/2016; the expiration date is 02/28/2017.Concomitant product information received 06/29/2016: webster cs with auto id ((b)(4)) model# d-1353-03-s, lot# 17127539m.The bwi failure analysis lab received the device for evaluation on 07/05/2016.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a soundstar® eco diagnostic ultrasound catheter and suffered a cardiac tamponade and cardiac arrest which required pericardiocentesis and surgical intervention.When the soundstar eco catheter was connected a non mdr reportable magnetic sensor error occurred.Upon receipt, the catheter was visually inspected and it was found in normal conditions.A carto test and coil disconnection test was performed and catheter failed specifications.The catheter was dissected and it was found that the y sensor coil did not pass specifications.Investigation found y sensor was discontinued at the tip.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Based on available analysis results, there was a coil sensor failure related to the recognition between the catheter and the carto 3 system.The failure of the coil sensor did not contribute to the tamponade.

• Brand Name: SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• 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: 5743625
• MDR Text Key: 48003895
• Report Number: 2029046-2016-00073
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140318
• 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,Followup,Followup
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: M-5723-17
• Device Catalogue Number: 10439011
• Device Lot Number: OEM_M-5723-17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2016
• 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