MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. WEBSTER ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Catalog Number WEB4POLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 03/15/2019

Event Type  Injury  

Manufacturer Narrative

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.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.Manufacturing record evaluation cannot be conducted because no lot number was provided by the reporter.Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a (b)(6) male patient enrolled into the magnetic vt (non-bwi sponsored) study in which a biosense webster inc.(bwi) webster¿ electrophysiology catheter (quadripolar rv) was used and patient suffered cardiac tamponade requiring pericardiocentesis.The patient had no prior ablation procedure.After retrograde approach, the patient was heparinized, and had undergone the ablation procedure using a maximum of 45 watts.Post-procedure, the bwi webster¿ electrophysiology catheter (quadripolar rv) was inserted into the patient¿s body to conduct programmed electrical stimulation (pes).Shortly after, the patient became hypotensive.Cardiac tamponade was confirmed and emergency pericardiocentesis was performed to remove 500 cc of blood from the pericardium.Patient¿s outcome is fully recovered with no impairment.There¿s no information regarding extended hospitalization and physician causality opinion.Patient¿s relevant history included ischemic cardiomyopathy with an ejection fraction (ef) less than 35%, coronary artery disease, myocardial infraction (mi) and an implantable cardioverter-defibrillator (icd).Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.

• Brand Name: WEBSTER ELECTROPHYSIOLOGY CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8587340
• MDR Text Key: 144300393
• Report Number: 2029046-2019-03076
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WEB4POLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 75 YR