MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THMCL SMARTTOUCH,TC,F,C3,OBL; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133605IL

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

Patient Problems Cardiac Arrest (1762); Death (1802); No Code Available (3191)

Event Date 02/21/2019

Event Type  Death  

Manufacturer Narrative

On 5/2/2019, the biosense webster inc.¿s product analysis lab received the device for evaluation.Initial visual analysis observed no physical damage on the returned device.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.A manufacturing record evaluation was performed for the finished device 30127252m number, and no internal actions related to the reported complaint condition were identified.Concomitant bwi product: pentaray nav eco catheter (us catalog # d128211; lot # 30122481l).(b)(6).(b)(4).

Event Description

It was reported that a (b)(6) male patient with history of atrial fibrillation (afib) underwent a supraventricular tachycardia (svt) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and a navistar¿ electrophysiology catheter and suffered cardiac arrest (requiring surgical intervention) and death.During the procedure, a navistar¿ electrophysiology catheter was inserted into the patient¿s body.After mapping and before ablation, the patient developed atrial fibrillation.The physician decided to change the navistar¿ electrophysiology catheter to a pentaray nav high-density mapping eco catheter and a thermocool® smart touch¿ electrophysiology catheter.Five minutes later, the physician prepared to set up the model, and found the patient had become unconscious and hypotensive.The patient developed cardiac arrest.An unspecified surgical intervention was performed; however, patient¿s condition did not improve and although the patient was recovered once, the patient expired.Physician¿s opinion regarding the cause of the death is that it was caused by acute heart failure or myocardial infraction.No bwi product malfunctions were reported.Biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: this mfr # for product code d133605il (thermocool® smart touch¿ electrophysiology catheter), mfr # 2029046-2019-03109 for product code ns7tcfl174hs (navistar¿ electrophysiology catheter).

Manufacturer Narrative

It was reported that a 60-year-old male patient with history of atrial fibrillation (afib) underwent a supraventricular tachycardia (svt) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and a navistar¿ electrophysiology catheter and suffered cardiac arrest (requiring surgical intervention) and death.After the physician prepared to set up the model, the patient had become unconscious and hypotensive.The patient developed cardiac arrest.An unspecified surgical intervention was performed; however, patient¿s condition did not improve and although the patient was recovered once, the patient expired.Physician¿s opinion regarding the cause of the death is that it was caused by acute heart failure or myocardial infraction.No bwi product malfunctions were reported.Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found in good conditions.The magnetic sensor was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor was tested and it was working properly, the force values were observed within specifications.An electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, the irrigation and deflection test were performed and it was found within specifications, the catheter was irrigating and deflecting correctly.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

On 10/22/2019, biosense webster inc.Received additional information about this event.It was reported that an intraoperative electrophysiological examination was performed routinely through femoral vein to diagnose atrioventricular node reentrant supraventricular tachycardia.Diagnostic/ablation adjustable tip catheter (navistar¿ electrophysiology catheter) was selected for mapping right atrium modeling.After modeling, the patient's vital signs were stable without complaints.At this time, electrocardiogram monitoring showed atrial fibrillation rhythm, sustained, and could not be terminated spontaneously.After communicating with the patient, the surgeon decided to initiate radiofrequency ablation of atrial fibrillation.At this point, the patient had no apparent discomfort and had stable vital signs.Atrial septal puncture needle and sheath were used in radiofrequency ablation of atrial fibrillation.Pentaray star mapping catheter and thermocool® smart touch¿ electrophysiology catheter diagnostic/ablation adjustable bend catheter were selected to model and ablate the left atrium.Sudden patient death and the use of diagnostic/ablation adjustable bend guide, right atrial mapping modeling is not directly relevant.After atrial septal puncture, a pentaray star-shaped magnetoelectric double-positioning mapping catheter and an adjustable bend catheter for thermocool® smart touch¿ electrophysiology catheter diagnostic ablation were introduced, without modelling, mapping, ablation, and so there was no significant association.Additionally, the following products have been added to concomitant products section: thmcl smarttouch,tc,f,c3,obl; def 7f ns,4p,f,1-7-4mm,hyp,115; pentaray nav eco 7fr, d, 2-6-2 and the unknown atrial septal puncture needle and sheath.Manufacturer's ref # (b)(4).

• Brand Name: THMCL SMARTTOUCH,TC,F,C3,OBL
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8599461
• MDR Text Key: 144711159
• Report Number: 2029046-2019-03108
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2019

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 Expiration Date: 10/22/2019
• Device Catalogue Number: D133605IL
• Device Lot Number: 30127252M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 06/26/2019; 10/22/2019
• Supplement Dates FDA Received: 07/16/2019; 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEF 7F NS,4P,F,1-7-4MM,HYP,115; PENTARAY NAV ECO 7FR, D, 2-6-2; UNKNOWN ATRIAL SEPTAL PUNCTURE NEEDLE AND SHEATH
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 60 YR