MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) NAVISTAR DS; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1201-19-S

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Rupture (2208); Cardiac Tamponade (2226); No Code Available (3191)

Event Date 03/21/2017

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant medical products: st.Jude medical brk-1 transseptal needle (model# and lot# unknown); boston scientific zurpas 8.5 french medium curl symmetric curve sheath (model# and lot# unknown).(b)(4).Event description continuation: generator parameters included temperature control mode at 70 watts (not titrated) with temperature at 50°c throughout the procedure.Overall ablation time and last ablation cycle time at the site of injury were not reported, as the injury was discovered post-procedure.There is no information regarding irrigated catheter flow setting.Patient received anticoagulant (angiomax) titrated to maintain activated clotting time at greater than 300 seconds.There were no error messages reported on any bwi equipment during the procedure.

Event Description

It was reported that an overweight female patient underwent an ablation procedure for atrial fibrillation with a navistar ds catheter and suffered a cardiac tamponade (requiring pericardiocentesis with pericardial drain) and cardiac valve rupture (requiring a surgical intervention).Post-procedure, while transferring the patient to the stretcher, she abruptly became hypotensive and a tamponade was confirmed via transthoracic echocardiogram.Pericardiocentesis was performed and an unknown amount of fluid was removed.Drain was left in place.Patient was reported to be in stable condition.Patient was admitted to the intensive care unit.Patient required extended hospitalization as a result of the adverse event.Patient remained hospitalized at the time of complaint update.Several days post-procedure, a leaky aortic valve was discovered.Aortic valve was replaced.It was noted that the patient had atypical left atrial roof anatomy.Factors cited that may have contributed to the adverse event include a large out pouching on the roof of the left atrium, found during fast anatomical mapping, that may have represented a perforation, a growth, or an aneurysm.Computed tomography (ct) did not reveal any growth.Physician speculated that the area of the ct with the potential growth may have been interpreted as artifact and cut off.Physician¿s opinion regarding the cause of the adverse event is that it is unclear, as the tamponade was discovered post-procedure.It was noted that the physician does not know where or when the injury occurred.By the echocardiogram, the tamponade appeared to have occurred on the right side, but ablation was only performed on the left side.Transseptal puncture was performed with a st.Jude medical brk-1 transseptal needle.Sheath in use was a boston scientific zurpas 8.5 french medium curl symmetric curve sheath.

• Brand Name: NAVISTAR DS
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6497784
• MDR Text Key: 72942103
• Report Number: 2029046-2017-00135
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2017

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: D-1201-19-S
• Device Catalogue Number: NS7TCF8L174HS
• Device Lot Number: UNKNOWN_D-1201-19-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention