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

Model Number	D-1317-08-S
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Date of Event	01/12/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The device history record (dhr) for the lot number 17564487l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation with an ez steer thermocool sf nav catheter and suffered a cardiac tamponade (requiring pericardiocentesis and surgical intervention) and death.During the second transseptal puncture, the patient became hypotensive and a tamponade was confirmed.Pericardiocentesis yielded a large amount of fluid (unspecified).Patient was reported to be in critical condition immediately after the event.There is no information regarding the length of hospitalization.Patient condition worsened, as they were transferred to a different facility for a surgical intervention and expired in the hospital.There were no factors cited that may have contributed to the adverse event.Physician indicated that the event was related to the second transseptal puncture, and not related to the ablation catheter.Sheath in use was a st.Jude medical s1.Generator parameters were not reported, as no ablation was performed.It was reported that the injury occurred as a result of transseptal puncture and was detected immediately.Irrigated catheter flow was set at 2ml/min.Patient received anticoagulant during the procedure with a standard target goal for activated clotting time of 300-350 seconds.There is no information regarding shaft proximity interference (spi) value, catheter proximity, or catheter re-zeroing.There were no errors reported on any bwi equipment during the procedure.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since this adverse event resulted in the patient¿s death, it is mdr reportable.

• 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: 6313314
• Report Number: 9673241-2017-00099
• Device Sequence Number: 1106633
• Product Code: LPB
• UDI-Device Identifier: 10846835003178
• UDI-Public: (01)10846835003178(11)160909(17)190831(10)17564487L
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/12/2017

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: 08/31/2019
• Device Model Number: D-1317-08-S
• Device Catalogue Number: BNI35BFH
• Device Lot Number: 17564487L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2017
• Initial Report FDA Received Date: 02/08/2017
• 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: Death; Required Intervention