MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D134803
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Not Applicable (3189)
Date of Event	04/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for paroxysmal atrial fibrillation with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a cardiac tamponade requiring pericardiocentesis and surgical intervention.During the procedure, while positioning the soundstar catheter, a small pericardial effusion was detected via ultrasound.The procedure continued.Transseptal puncture was performed x 2 with an unspecified transseptal needle.The smarttouch sf catheter and the lasso catheter were positioned in the left atrium.Pericardial effusion was noted to have increased.Remainder of the procedure was aborted.Catheters were removed.Pericardiocentesis yielded an unspecified volume of fluid.Patient underwent a surgical intervention.Patient was reported to be in stable condition.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.
Additional Manufacturer Narrative
On 5/11/2018, additional information was received which indicates the patient is a (b)(6) year-old female who underwent an ablation procedure for drug-refractory paroxysmal atrial fibrillation.During mapping phase, while positioning the soundstar catheter, a small pericardial effusion was detected.The procedure continued.Transseptal puncture was performed x 2 with a merit medical heartspan transseptal needle.During mapping phase, while positioning the soundstar catheter, a small pericardial effusion was detected.The procedure continued.Transseptal puncture was performed x 2 with a merit medical heartspan transseptal needle.The smarttouch sf catheter and the lasso catheter were positioned in the left atrium.Pericardial effusion was noted to have increased.Remainder of the procedure was aborted.Catheters were removed.Pericardiocentesis yielded an unspecified volume of fluid.Patient underwent a surgical intervention (sternotomy and pericardial drainage tube placement).Patient was reported to be in stable condition.Patient required extended hospitalization as a result of the adverse event for surgical recovery and recurrent atrial fibrillation.Patient outcome is improved.Factors cited that may have contributed to the adverse event include that the patient was on eliquis at the time of the procedure.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.There were no issues, errors, or malfunctions reported on any bwi products or equipment during the procedure.Transseptal puncture was performed with a merit medical heartspan transseptal needle and a st.Jude medical 8.5 french sl-1 sheath.There is no information regarding generator parameters, generator settings, power titration, overall ablation time at the site of injury, or last ablation cycle time at the site of injury, as no ablation was performed.Irrigated catheter flow was set on 2 ml/min during mapping.Patient received anticoagulant during the procedure with activated clotting time (act) maintained between 250-300 seconds.There is no information regarding spi value.Smarttouch sf catheter was in close proximity to the lasso catheter during the procedure.Smarttouch sf catheter was zeroed after the initial warm-up phase, post catheter connection to the carto 3 patient interface unit.Carto 3 system did not indicate to re-zero the catheter.There were no issues, errors, or malfunctions reported on any bwi products or equipment during the procedure.Concomitant products include: bwi products: lasso catheter (catalog # unknown, lot # unknown); carto 3 system (catalog # unknown, serial # unknown) distributed products: merit medical heartspan transseptal needle.Non-bwi products: st.Jude medical 8.5 french sl-1 sheath.Manufacturer¿s ref # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 7488731
• Report Number: 2029046-2018-01515
• Device Sequence Number: 16657454
• Product Code: LPB
• UDI-Device Identifier: 10846835010169
• UDI-Public: 10846835010169
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: D134803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 70