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 Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event description continuation: there were no errors reported on any bwi equipment during the procedure.Patient received anticoagulant during the procedure with activated clotting time maintained in an unspecified range.It was noted that the patient¿s hemoglobin and hematocrit were low.Since two ablation catheters were used prior to the adverse event, this complaint will be reported under both catheter used.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 medical products: mobicath vascular access sheath (model# unknown lot# unknown); carto 3 system (model# unknown serial# unknown).(b)(4).Biosense webster manufacturer's ref.No.'s (b)(4) are related to the same incident.
Event or Problem Description
It was reported that an (b)(6) female patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure for premature ventricular contractions (pvcs) with an thermocool® sf nav bi-directional catheter and suffered a cardiac tamponade requiring pericardiocentesis and surgical intervention.Noise displayed on the distal electrodes of the thermocool® smarttouch® sf bi-directional nav catheter (catheter #1).The cable was replaced and error 105 and eeprom data error displayed on the carto 3 system.The catheter was exchanged for a thermocool® sf nav bi-directional catheter (catheter # 2), since a replacement thermocool® smarttouch® sf bi-directional nav catheter was not available.The noise issue and errors are not mdr reportable because the risk to the patient is low.After mapping with the thermocool® sf nav bi-directional catheter, the patient became hypotensive and a tamponade was confirmed via echocardiogram.A pericardiocentesis was performed and yielded an unspecified amount of fluid.The patient was reported to be in stable condition at the time of complaint report.Patient required extended hospitalization as a result of the adverse event for recovery from surgery.Patient fully recovered with no residual effects.There were no additional factors cited that may have contributed to the adverse event.Physician¿s opinion regarding the cause of the adverse event is that the pulmonary artery was perforated while mapping pvcs.It was noted that the adverse event was not related to any product malfunction.No transseptal puncture was performed.Sheath was a mobicath vascular access sheath.Generator parameters and settings at the time of injury were not reported, as no ablation was performed.Overall ablation time and last ablation cycle time at the site of injury were not reported, as no ablation was performed.Irrigated catheter flow was set at 2ml/min.
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 05/25/2017.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).
Additional Manufacturer Narrative
(b)(4) it was reported that an (b)(6) female patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure for premature ventricular contractions (pvcs) with an thermocool® sf nav bi-directional catheter and suffered a cardiac tamponade requiring pericardiocentesis and surgical intervention.The catheter was visually inspected in detail and it was found in normal conditions.Then the catheter performed an electrical performance, temperature response and generator test and it was found within specifications.A deflection test was performed and the catheter passed.The catheter was evaluated for eeprom, and the functionality of the sensors of the catheter was tested on the carto 3 system.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.Finally, an irrigation test was performed and the catheter passed, no occlusion was observed.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.The catheter passed all specifications.The root cause of the cardiac tamponade remains unknown.The instructions for use states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• 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: 6589660
• Report Number: 9673241-2017-00398
• Device Sequence Number: 10843911
• Product Code: LPB
• UDI-Device Identifier: 10846835003208
• UDI-Public: (01)10846835003208(11)161013(17)190930(10)17592832L
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2017

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: 09/30/2019
• Device Model Number: D-1313-05-S
• Device Catalogue Number: BNI35DFCT
• Device Lot Number: 17592832L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: Not provided; 05/01/2017
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 05/30/2017; 07/17/2017
• 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; Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 50