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

Model Number	D-1313-05-S
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	02/28/2015
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 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 were used in this study: 4-mm-tip non-irrigated-tip catheter navistar catheter other companies devices were not used in this study.(b)(4).This product is not returned to bwi.
Event or Problem Description
This complaint is from a literature source.It was reported that with 130 consecutive patients who underwent catheter ablation of idiopathic left bundle block morphology (dominant s wave in lead v1) ot-vas between january 2010 and february 2015.Among them, 1 patient in the pbv2 group suffered pericardial effusion without cardiac compression and treated with pericardiocentesis.Additional information was received on the event.It was reported one (b)(6) female ((b)(6)) patient in the pbv2 group suffered pericardial effusion without cardiac compression and treated with pericardiocentesis.Patient required additional one-day observation and fully recovered.Lot # 16050905l thermocool sf nav 7.5f df catheter was used in this event.The author stated that bwi device possibly led to the reported patient consequence, and the event was procedure related.The event did not result in the impairment of a body function or damage to a body structure.Title: ¿outcomes of catheter ablation of idiopathic outflow tract ventricular arrhythmias with an r wave pattern break in lead v2: a distinct clinical entity¿ the purpose of this study was to characterize the anatomic origin, electrophysiological features, and outcomes of catheter ablation of outflow tract ventricular arrhythmias with a pattern break in lead v2.

• 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: 6498108
• Report Number: 9673241-2017-00290
• Device Sequence Number: 1170800
• Product Code: LPB
• UDI-Device Identifier: 10846835003208
• UDI-Public: (01)10846835003208(11)140130(17)170131(10)16050905L
• 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: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: D-1313-05-S
• Device Catalogue Number: BNI35DFCT
• Device Lot Number: 16050905L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2017
• Initial Report FDA Received Date: 04/17/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 95