MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR® THERMOCOOL®; SIMILAR DEVICE NI75TCJH, PMA # P030031

Model Number D-1197-00

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cardiac Tamponade (2226)

Event Date 01/01/2012

Event Type  Injury  

Event Description

This complaint is from literature source.One patient developed cardiac tamponade soon after transseptal puncture with an nih catheter manipulation to image the pvs.Article title: ¿safety and efficacy of multipolar pulmonary vein ablation catheter vs.Irrigated radiofrequency ablation for paroxysmal atrial fibrillation: a randomized multicenter trial¿.The goal of this randomized controlled trial was to assesses the medium-term efficacy of duty-cycled radiofrequency ablation via the circular pulmonary vein ablation catheter (pvac) vs.Conventional electro-anatomically guided wide-area circumferential ablation (waca).A total of 188 paf patients underwent cardiac ablation procedure between september 2007 and march 2012.From the article other complication were reported: 1 patient developed cardiac tamponade soon after transseptal puncture during geometry creation with manipulation of the ablation catheter in the left atrial appendage; 1 patient developed cardiac tamponade due to steam pop during left-sided waca applying 30w near the la roof.

Manufacturer Narrative

(b)(4).One patient underwent circular pulmonary vein ablation and subsequently developed cerebrovascular accident.The patient had a prior history of transient ischemic attack (tia) and hypertension with chadsvasc score of 3.He had commenced fragmin pre-operatively and stopped warfarin 3 days before, his pre-op inr was 1.5.He had a normal pre-operative transesophageal echocardiogram (tee) and had therapeutic inr¿s pre-procedure with heparin bridging and act¿s of 250 s initially to.300 s during the procedure, post-procedural protamine and therapeutic lmw heparin as per usual protocol.The following morning post-procedure, he had a homonymous hemianopia secondary to an occipital infarct which did not recover.It was not possible to know the exact timing of this event as he had returned to the ward sedated that evening and did not notice the field defect until the next morning.Per author assessment this adverse event might be either catheter related (char, coagulum or air embolisation) or developed as a result of thrombus formation on the ablation lesions overnight despite post-operative anticoagulation.Per article this vascular pseudoaneurism occurred in pvac group (pulmonary vein ablation catheter, medtronic ablation frontiers).Non-bwi catheters were used during this procedure.One patient had cerebrovascular accident (right eye inferior quadrant field defect) 2 days post ablation with pvac.An magnetic resonance imaging (mri) confirmed two small infarcts in the fronto-parietal lobes.He had a normal pre-operative tee and therapeutic inrs having stopped warfarin with heparin cover 3 days pre-op with an inr of 1.2 on the day of procedure.Act¿s during the procedure had been between 260 and 320 s.His ablation had been unremarkable, but had required dc cardioversion at the end of the case as he developed af during catheter manipulation.He received postoperative protamine.He had been on therapeutic doses of lmw heparin while recommencing warfarin and had a pre-op chadsvasc score of 0.This field defect did not recover.Per article, this vascular pseudoaneurism occurred in pvac group (pulmonary vein ablation catheter, medtronic ablation frontiers).Non-bwi catheters were used during this procedure.One patient in waca group developed clinical pv stenosis 12 months post-procedure.This patient had a geometry shift during ablation requiring remapping with navx and it is likely that rf was inadvertently delivered too close to the pv common ostium.He had a delayed presentation with increasing exertional dyspnea 12 months post ablation requiring venoplasty to the left upper and left lower pulmonary vein (lu and llpv).One patients (pvac group) had a repeat af ablation procedure with pv angiography, it was noted that the lupv had a mild 40% stenosis.Per article this vascular pseudoaneurism occurred in pvac group (pulmonary vein ablation catheter, medtronic ablation frontiers).Non-bwi catheters were used during this procedure.One patients (pvac group) had a repeat af ablation procedure with pv angiography, it was noted that the lupv had a mild 50% stenosis.The latter resulted in a 5 mmhg pressure gradient but since the patient did not have any symptoms, it did not require angioplasty.Per article this vascular pseudoaneurism occurred in pvac group (pulmonary vein ablation catheter, medtronic ablation frontiers).Non-bwi catheters were used during this procedure.One patient (pvac group) developed a pseudo-aneurysm 24 h post-procedure requiring thrombin injection but did not suffer any long term sequelae.Per article this vascular pseudoaneurism occurred in pvac group (pulmonary vein ablation catheter, medtronic ablation frontiers).Non-bwi catheters were used during this procedure.One patient died due to heart failure 11 months post-procedure.The following bwi products were used during this trial.Thermocool and carto ammping system.However catalog and lot number are not available.Non-bwi products were also used during this study.Coolpath duo 7 fr, st jude medical coolflex, navx mapping system, sl1 and agilis guide sheath, genius (medtronic, inc.) rf generator.

• Brand Name: NAVISTAR® THERMOCOOL®
• Type of Device: SIMILAR DEVICE NI75TCJH, PMA # P030031
• 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: 4219741
• MDR Text Key: 20750763
• Report Number: 2029046-2014-00409
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1197-00
• Device Lot Number: UNKNOWN_NAVISTAR THERMO TC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR