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

Model Number	D-1315-02-S
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Date of Event	12/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clotting time maintained between 250-300 seconds.Act at the time of injury was 301 seconds.There is no information regarding spi value.Thermocool smarttouch uni-directional catheter was 6.6 mm away from another catheter.Thermocool smarttouch uni-directional catheter was zeroed after the initial warm-up phase, post-connection to the carto 3 patient interface unit.Carto 3 system did not indicate to re-zero the catheter.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.Since the thermocool smarttouch uni-directional catheter and thermocool sf navigation catheter were used in the patient, this event will be conservatively reported under both of these catheters.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 17310225l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.Concomitant products: nogastar catheter, model #: 120707s, lot #: 17561907m.Carto 3 system, model #: m-4800-01, serial #: (b)(4).Stockert generator.(b)(4) are related to the same incident.(b)(4).
Event or Problem Description
This pi is part of (b)(6) clinical study "bipolar ablation for endocardial and epicardial simultaneous ablation of vt¿: it was reported that a male patient underwent an ablation procedure for ischemic ventricular tachycardia with a thermocool smarttouch uni-directional catheter and thermocool sf navigation catheter and suffered a cardiac tamponade requiring pericardiocentesis and pericardial drain.During the study, mid-procedure, the patient became hypotensive and a tamponade was confirmed via fluoroscopy.Protamine was administered for anticoagulant reversal.Pericardiocentesis yielded an unknown amount of fluid.Pericardial drain was left in place.Patient remained in the hospital overnight for observation.There is no information regarding extended hospitalization.Patient fully recovered with no residual effects.There were no factors cited that may have contributed to the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was related to patient condition and not to any biosense webster, inc.Product.Transseptal puncture was performed with an unspecified needle.There is no sheath information.Generator was reported to be set to default parameters.Power was titrated.Overall ablation time and last ablation cycle time at the site of injury were not reported, as site of injury is unknown.Irrigated catheter flow was set at 30 ml/min.Patient received anticoagulant during the procedure with activated.

• 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: 6262487
• Report Number: 9673241-2017-00060
• Device Sequence Number: 10970432
• Product Code: LPB
• UDI-Device Identifier: 10846835009248
• UDI-Public: (01)10846835009248(11)150904(17)180831(10)17310225L
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/20/2016

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: 08/31/2018
• Device Model Number: D-1315-02-S
• Device Catalogue Number: D131502
• Device Lot Number: 17310225L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2016
• Initial Report FDA Received Date: 01/18/2017
• 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