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

Model Number NAVISTAR TC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Stroke/CVA (1770); Hematoma (1884); Hemorrhage/Bleeding (1888); Transient Ischemic Attack (2109); Cardiac Tamponade (2226); Stenosis (2263); Respiratory Tract Infection (2420); Pericardial Effusion (3271)

Event Date 06/05/2008

Event Type  Injury  

Event Description

Biosense webster reviewed "randomized trial comparing robotic to manual ablation for atrial fibrillation, heart rhythm" article and upon following up with the customer, bwi received additional information on (b)(4) 2014.This complaint is being opened for the procedure conducted on (b)(6) 2008.The patient suffered from cardiac tamponade.However, it's unknown the patient underwent additional surgery.Model and catalog number are not available, but the suspected device is the thermocool catheter.Per a report in the journal of heart rhythm, a single-center randomized study was conducted on 157 patients, by (b)(6) hospital, to assess the impact of remote robotic navigation on one year single-procedure success rates.From the report there were 13 (thirteen) patients with serious adverse events (these events will be reported separately): patient # 1 ((b)(4)): transient ischemic attack /pericardial effusion/lower respiratory tract infection.Patient # 2 ((b)(4)): cerebrovascular accident/death; patient #3 ((b)(4)): retroperitoneal bleed; patient #4 ((b)(4)): retroperitoneal bleed; patient #5 ((b)(4)):major pulmonary vein stenosis; patient #7 ((b)(4)): lower respiratory tract infection; patient #8 ((b)(4)): tamponade; patient #10 ((b)(4)): minor pulmonary vein stenosis; patient #16 ((b)(4)): lower respiratory tract infection; patient #20 (pi1-nz6o4m): pericardial effusion/ lower respiratory tract infection.Per the article, other non-serious ae¿s were also reported: - 6 pericardial effusion; - 8 hematoma; - 1 pulmonary vein stenosis; these events are not known to have required intervention/treatment nor extended hospitalization stay.There is a death event and no bwi device malfunctions reported in the publication.

Manufacturer Narrative

(b)(4).

• 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: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4118466
• MDR Text Key: 19089964
• Report Number: 2029046-2014-00320
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P990025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2014

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: NAVISTAR TC
• Device Lot Number: UNKNOWN_NAVISTAR TC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 09/25/2014
• 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
• Patient Age: 78 YR