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 Codes	Perforation of Vessels (2135); Atrial Perforation (2511)
Date of Event	06/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: ep shuttle rf generator (model# 39d-76x serial# (b)(4)).Carto 3 system.Webster 10 pole (model# d-1079-230-s lot# 17284508m).Webster 8 pole (model# d-1079-213-s lot# 17375155m).Carto 3 ref patch (model# d-1283-02 lot#ll010690).(b)(4).
Event or Problem Description
It was reported that a female patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation and an electrophysiology study with radiofrequency ablation for atrioventricular reentrant tachycardia (avrt) with a thermocoolsf nav bi-directional catheter and suffered a vessel perforation requiring non-surgical drainage.During the transseptal puncture, a vessel perforation was suspected.Aortic perforation was confirmed via fluoroscopy.Blood was drained via a non-surgical approach.Remainder of procedure was cancelled, no ablation had been performed.Patient was reported to be in stable condition throughout the procedure.Patient was transferred back to the ward.Patient did not require extended hospitalization.Patient has fully recovered.Physician's opinion regarding the cause of the adverse event is that it was procedure-related.There were no complaints of failure with the carto 3 system.It was noted that no catheter was believed to have caused the adverse event, as no catheter was involved with transseptal puncture.However, biosense webster catheters were in place at the time the injury was discovered, therefore this event is being conservatively reported.
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 07/21/2016.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 a female patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation and an electrophysiology study with radiofrequency ablation for atrioventricular reentrant tachycardia (avrt) with a thermocool sf nav bi-directional catheter and suffered a vessel perforation requiring non-surgical drainage.The returned device was visually inspected and it was found in normal conditions.A deflection test was performed and the catheter passed.The catheter was evaluated for eeprom, and the functionality of the sensor of the catheter was tested on carto 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.An irrigation test was performed and the catheter passed, no occlusion was observed.The catheter was tested for electrical performance, temperature response and generator test and failed on electrode #5 during electrical test.Further examination revealed that the lead wire # 5 was broken causing the improper signal condition.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.Catheter failed during electrical test; however this condition is not related to the vessel perforation reported.The root cause of the vessel perforation remains unknown.The ifu 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: 5794477
• Report Number: 9673241-2016-00438
• Device Sequence Number: 18838654
• Product Code: LPB
• UDI-Device Identifier: 10846835003130
• UDI-Public: (01)10846835003130(11)151215(17)181130(10)17381501L
• 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,Followup,Followup
• Report Date (Section B): 06/22/2016

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: 11/30/2018
• Device Model Number: D-1317-06-S
• Device Catalogue Number: BNI35BBH
• Device Lot Number: 17381501L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/22/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/14/2016
• Supplement Report FDA Received Date: 08/09/2016; 08/26/2016
• 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