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

Model Number	D-1315-03-S
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Date of Event	06/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant products: carto 3 system, model # m-4800-01, s/n: (b)(4).Stockert generator.Transseptal needle.Agilis 8.5 french sheath.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool sf nav catheter and suffered a cardiac tamponade requiring surgical intervention.During the procedure, the patient became hypotensive and a tamponade was confirmed by intracardiac echocardiogram.Pericardiocentesis yielded 1300cc.Patient was sent for surgical intervention.There is no information regarding the patient's status.Physician did not provide a causality opinion.Transseptal puncture was performed with an unknown needle.Sheath used was an agilis 8.5 french.Generator settings included power at 40 watts (not titrated) with 20 watts on the posterior wall.All other parameters were default for sf catheters.Overall ablation time at the site of injury was 15 minutes.Last ablation cycle time at the site of injury is unknown.Irrigated catheter flow was set at 8ml/min at 20 watts and 15 ml/min at 40 watts.There were no error messages observed on any bwi equipment during the procedure.Patient received anticoagulant (heparin) during the procedure with activated clotting times maintained in an unknown range.

• Brand Name: THERMOCOOL® SF NAV UNI-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: 5818289
• Report Number: 9673241-2016-00449
• Device Sequence Number: 5888
• Product Code: LPB
• UDI-Device Identifier: 10846835009293
• UDI-Public: (01)10846835009293(11)160210(17)190131(10)17413551L
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S034
• 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): 06/30/2016

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: 01/31/2019
• Device Model Number: D-1315-03-S
• Device Catalogue Number: D131503
• Device Lot Number: 17413551L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2016
• Initial Report FDA Received Date: 07/24/2016
• 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: Life Threatening; Required Intervention
• Patient Age: 82 YR