MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D-1313-02-S
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Date of Event	11/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record (dhr) for the lot number 17581344l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).Event description continuation: power was titrated depending on location, not individual lesion.Overall ablation time and last ablation cycle time at the site of injury were not reported, as no ablation was performed at the site of injury.Irrigated catheter flow was set on default settings.The patient received anticoagulant during the procedure with activated clotting time maintained at the target of 350 seconds.There were no error messages reported on any biosense webster inc.Equipment during the procedure.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.
Event or Problem Description
It was reported that a (b)(6) male patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation with an ez steer thermocool sf navigational catheter and suffered a cardiac tamponade requiring a pericardiocentesis and surgical intervention.After left pvi (and prior to right pvi), the agilis sheath was advanced through the transseptal puncture site into the left atrium.A few minutes later, the patient became hypotensive.The cardiac tamponade was confirmed via intravascular ultrasound (ivus) through the agilis sheath.The pericardiocentesis yielded an unknown amount of fluid.Remainder of the procedure was aborted.The patient was reported to be in stable condition.The patient required extended hospitalization as a result of the adverse event in order to recover from thoracic surgery.The patient fully recovered with no residual effects.There were no factors cited that may have contributed to the adverse event.The physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.It was noted that the issue seemed to be unrelated to any biosense webster, inc.Products.Event occurred 5 minutes after the agilis sheath was re-inserted through the transseptal puncture, post left pvi.The transseptal puncture was performed with a baylis transseptal needle.Sheaths used were st.Jude medical agilis x 2 (1 for the ablation catheter and 1 for the ivus).The generator parameters at the time of injury included power control mode at 20-30 watts and default stockert generator settings.

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• MDR Report Key: 6146518
• Report Number: 9673241-2016-00831
• Device Sequence Number: 13621999
• Product Code: LPB
• UDI-Device Identifier: 10846835003246
• UDI-Public: (01)10846835003246(11)161005(17)190930(10)17581344L
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S025
• 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
• Report Date (Section B): 11/08/2016

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 Expiration Date: 09/30/2019
• Device Model Number: D-1313-02-S
• Device Catalogue Number: BNI35FFCT
• Device Lot Number: 17581344L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2016
• Initial Report FDA Received Date: 12/05/2016
• 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: 77 YR