MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) ELECTRODE, PACEMAKER, TEMPORARY

Model Number D-1086-721-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/27/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant products were used during this study: smarttouch thermocool catheter.(b)(4).Methods: no testing methods performed.Results: no results available since no evaluation performed.Conclusion: device discarded by user, unable to follow-up.(b)(4).The device was not returned to bwi.

Event Description

It was reported that a patient underwent idvt ablation and suffered cardiac tamponade which was treated with pericardiocentesis during mapping phase.200ml fluid was removed.The patient was fully recovered.The physician assessed that the cause of the adverse event could be caused by quadripolar catheter due to a mechanic movement of the ventricle.

Manufacturer Narrative

The device history record (dhr) for the lot number 17282446m has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 01/20/2016.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 Narrative

New information: two biosense webster (bw) catheters were introduced in the rv, the webster® quadrapolar fixed catheter placed near the septum of the ventricle and the thermocool® smarttouch¿ sf bi-directional catheter used to create the map.The event occurred during mapping phase.The patient was required extended hospitalization.One week hospitalized, two first days in intensive care unit.No transseptal puncture or ablation was performed.The patient did not receive anticoagulation.The patient is still with ventricular tachycardia.The flow setting of irrigated catheter is 2ml/min.The physician did not consider cancelling the procedure caused a potential risk to this patient.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure for idiopathic ventricular tachycardia with a webster quadrapolar catheter and suffered a cardiac tamponade requiring pericardiocentesis.Two biosense webster catheters were introduced in the right ventricle: the webster® quadrapolar fixed catheter was placed near the septum of the ventricle and the thermocool® smarttouch¿ sf bi-directional catheter was used to create the map.During mapping, patient became hypotensive and tamponade confirmed via echocardiogram.Procedure aborted.Pericardiocentesis yielded 200 cc.Patient stable immediately after event with normal blood pressures.Patient required extended hospitalization for one week as a result of the adverse event.Patient fully recovered with no residual effects.Physician¿s opinion regarding cause of adverse event is that the tamponade could have been caused by the webster quadrapolar catheter due to mechanical movement of the ventricle.Upon received the catheter was visually inspected and it was found in normal condition.Per the event, the catheter was tested for electrical performance it was found within specifications.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.The catheter passed all specifications.The root cause of the cardiac tamponade remains unknown.The ifu states that careful catheter manipulation must be performed in order to avoid cardiac tamponade.

• Brand Name: ELECTRODE, PACEMAKER, TEMPORARY
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• 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 ; 9497893837
• MDR Report Key: 5233411
• MDR Text Key: 31517986
• Report Number: 9673241-2015-00837
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K892265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: D-1086-721-S
• Device Catalogue Number: F6QA005RT
• Device Lot Number: 17282446M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention