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

Model Number	D-1317-06-S
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	07/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was also noted that heparin and dabigatran were reversed after the effusion.There were no errors reported on any bwi equipment during the procedure.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 external reference patch (model# d-1283-02 lot# ll013454).Webster cs 10 pole (model#d-1317-07-s lot# 17596626m).Cook medical transseptal needle (refg02364/7524323).St.Jude medical sl0 8 french sheath (ref407449/5881841).(b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent a redo pulmonary vein isolation (pvi) ablation procedure under general anesthesia for atrial fibrillation and atrial ectopy with an thermocool® sf nav bi-directional catheter and suffered a pericardial effusion requiring extended hospitalization.Coronary sinus (cs) catheter was placed in the cs, transseptal puncture was performed, and the thermocool® sf nav bi-directional catheter was positioned in the right atrium for mapping.A x-ray revealed contrast medium in the pericardial space.Patient remained hemodynamically stable throughout.Remainder of procedure was aborted.Patient remained in the catheterization lab under general anesthesia while the physician evaluated the severity of the effusion/perforation.After approximately 45-60 minutes, the patient emerged from anesthesia and was transferred to the intensive care unit (icu) for monitoring.Patient was under general anesthesia for 90 minutes.Patient required one day of extended hospitalization as a result of the adverse event for monitoring.Patient has since fully recovered.Factors cited that may have contributed to the adverse event include a narrow anatomical window for transseptal puncture.It was noted that the event occurred during transseptal phase.Physician¿s opinion regarding the cause of the adverse event is that it was related to procedure or patient condition.Transseptal puncture was performed with a cook medical transseptal needle.Sheath in use was a st.Jude medical sl0 8 french sheath.Generator parameters, generator settings, power titration, overall ablation time at the site of injury, and last ablation cycle time at the site of injury were not reported, as no ablation was performed.Patient received anticoagulant (heparin 8000 units) during the procedure.No activated clotting time was reported.It was noted that oral dabigatran was taken pre-procedure.

• 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: 6753706
• Report Number: 9673241-2017-00607
• Device Sequence Number: 162664
• Product Code: LPB
• UDI-Device Identifier: 10846835003130
• UDI-Public: (01)10846835003130(11)170328(17)200228(10)17660960L
• Combination Product (Y/N): N
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2017

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: 02/28/2020
• Device Model Number: D-1317-06-S
• Device Catalogue Number: BNI35BBH
• Device Lot Number: 17660960L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 07/31/2017
• 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: Hospitalization
• Patient Age: 76 YR
• Patient Weight: 83