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

Model Number	D-1317-07-S
Health Effect - Clinical Code	ST Segment Elevation (2059)
Date of Event	12/02/2016
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 product: pentaray catheter.Coolflow irrigation tubing (model# d-1233-18-s).Webster 10 pole catheter (model# d-1079-230-s lot# 17523031m).(b)(4) are related to the same incident.
Event or Problem Description
It was reported that a (b)(6) female patient underwent an ablation procedure for atypical atrial flutter with a thermocool sf nav uni-directional catheter and thermocool sf nav bi-directional catheter and suffered an acute myocardial infarction (ami) requiring pacing and cardiac arrest requiring cardiopulmonary resuscitation (cpr) and pharmacologic support.During ablation, st elevation was noted in the inferior leads (ii, iii, and avf).Patient was paced via the ablation catheter in the right ventricular apex.Patient went into cardiac arrest and cpr was initiated and pharmacologic support was provided.Coronary angiogram revealed no pathology.Patient was transferred to the intensive care unit.There is no information regarding extended hospitalization.It was noted that the patient remained in atrial flutter throughout the procedure.The flutter was unaltered by the event or by the ablation procedure at that time.It was also noted that the patient later returned to sinus rhythm.Patient has a history of prior pulmonary vein isolation (pvi) ablation.Physician is uncertain regarding the cause of the adverse event.Physician confirmed that the adverse event was not caused by bwi products.It was also noted that char was observed on the thermocool sf nav bi-directional catheter approximately 3 hours into the procedure.Catheter was replaced with the thermocool sf nav uni-directional catheter.It was noted that the irrigation bags were above minimum fluid levels and the pentaray pressure bag was within normal limits.Adverse event occurred approximately 5 minutes after catheter replacement.The charring discovered is not mdr reportable because char is a physical phenomenon of rf and can be the normal result of an ablation process.The presence of char on the electrodes does not represent a serious injury in itself nor is necessarily the result of device malfunction.
Additional Manufacturer Narrative
Incorrect udi submitted in initial report.The correct udi number is its corresponding field of this report.The bwi failure analysis lab received the device for evaluation on 01/09/2016.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 (b)(6) female patient underwent an ablation procedure for atypical atrial flutter with a thermocool® sf nav bi-directional catheter and suffered an acute myocardial infarction (ami) requiring pacing and cardiac arrest requiring cardiopulmonary resuscitation (cpr) and pharmacologic support.It was also noted that char was observed on the thermocool® sf nav bi-directional catheter approximately 3 hours into the procedure.The returned device was visually inspected and it was found in normal conditions.No sign of char was observed on the catheter tip.Per the event, the catheter was tested for electrical performance, temperature response and generator test and it was found within specifications.After that, deflection test was performed and the catheter passed.Then, an irrigation test was performed and the catheter passed, no occlusion was observed.Finally, the catheter was evaluated for eeprom, carto 3 and sensor functionality.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter failed carto 3 test due to reverse icon was visualized during the test.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 customer complaint regarding char issues cannot be confirmed.The root cause of the char reported remains unknown.Based on available analysis finding results, the failure mode does not appear to be caused by any internal bwi processes.An internal corrective action was created to address visualization issue as spinning, jumping or reverse icon.

• 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: 6215543
• Report Number: 9673241-2016-00918
• Device Sequence Number: 13569046
• Product Code: LPB
• UDI-Device Identifier: 10846835003154
• UDI-Public: (01)10846835003154(11)160727(17)170630(10)17518678L
• 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): 12/05/2016

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: 06/30/2019
• Device Model Number: D-1317-07-S
• Device Catalogue Number: BNI35BDH
• Device Lot Number: 17518678L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/02/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/30/2016
• Supplement Report FDA Received Date: 01/11/2017; 01/31/2017
• 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: Life Threatening; Required Intervention
• Patient Age: 65 YR