PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
Report
- Report Number
- 9673241-2014-00489
- Event Type
- Injury
- Date Received
- November 14, 2014
- Date of Event
- October 20, 2014
- Report Date
- October 20, 2014
- Manufacturer
- BIOSENSE WEBSTER, INC. (JUAREZ)
- Product Code
- MTD
- PMA / PMN Number
- K123837
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON DECEMBER 3, 2014. 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).
NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. 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 WAS REVIEWED. THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM (MODEL#M-4800-01 SERIAL# (B)(4)); STOCKERT 70 SYSTEM (MODEL# M-5463-01 SERIAL# (B)(4)); COOLFLOW PUMP (MODEL# UNKNOWN SERIAL# UNKNOWN); EZ STEER THERMOCOOL SF NAVIGATIONAL CATHETER (MODEL# D-1313-05-S LOT# 17071352L); WEBSTER 4 POLE WITH AUTO ID CATHETER (MODEL# D-1079-259-S LOT# 16104547M); WEBSTER 8 POLE CATHETER (MODEL# D-1079-213-S LOT# 16037665M); ACUNAV CATHETER (MODEL#M-5723-09 LOT# OEM). (B)(4).
THIS SUPPLEMENTAL REPORT IS IN RESPONSE TO THE FDA REQUEST DATED DECEMBER 19, 2014. PLEASE CONFIRM OR PROVIDE THE MODEL, LOT, SERIAL AND/OR CATALOG NUMBER(S) OF THE DEVICE LISTED IN THE MEDICAL DEVICE REPORT AS APPLICABLE. RESPONSE: THE PRODUCT INFORMATION IS MODEL NUMBER D-1282-11-S, LOT NUMBER 17098800L, CATALOG NUMBER D128211. PLEASE PROVIDE A SUMMARY OF THE RESULTS FOR ANY INVESTIGATION, EVALUATION, AND/OR FAILURE ANALYSIS, INCLUDING ROOT CAUSE IDENTIFICATION, RELEVANT TO THE REPORTED EVENT. PLEASE INCLUDE: A COMPLETE DESCRIPTION OF METHODOLOGY(IES) USED, AN IDENTIFICATION OF THE SPECIFIC FAILURE MODE(S) AND/OR MECHANISM(S) AND THE ASSOCIATED DEVICE COMPONENTS(S) INVOLVED, AND ANY CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS. RESPONSE: THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE THE CATHETER WAS ALSO EVALUATED FOR CARTO 3. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. FINALLY AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER FAILED. CATHETER WAS DISSECTED AND IT WAS FOUND THAT THE IRRIGATION TUBING WAS FOLDED AT THE TIP TRANSITION AREA. 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 FAILED THE IRRIGATION TEST, HOWEVER IT IS UNRELATED TO THE CAUSE OF THE CARDIAC TAMPONADE. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. MANAGEMENT IS NOTIFIED OF FAILURE ANALYSIS RESULTS USING MONTHLY COMPLAINT TREND REPORTING. A CORRECTIVE ACTION WAS CREATED TO ADDRESS THE PENTARAY NAV OCCLUSION/LEAK ISSUES. PLEASE PROVIDE ANY EVALUATION OF THE EVENT DESCRIBED IN THE MEDICAL DEVICE REPORT BY THE ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR HEALTH CARE PROFESSIONAL. RESPONSE: THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS PROCEDURE RELATED. THE EVENT OCCURRED DURING THE MAPPING PHASE WHILE THE PHYSICIAN WAS USING A PENTARAY NAVIGATIONAL ECO CATHETER. BASED ON THE INFORMATION RECEIVED DURING FOLLOW UP THERE WAS NO RESPONSE TO FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. PLEASE PROVIDE THE DISPOSITION OF THE DEVICE, INCLUDING INFORMATION ON YOUR DEVICE ACQUISITION EFFORTS. FOR REUSABLE DEVICES, INDICATE WHETHER THE DEVICE IS STILL IN USE. RESPONSE: BIOSENSE WEBSTER PRODUCTS ARE SINGLE USE DEVICES. THE PRODUCT WAS RETURNED TO BWI FOR ANALYSIS AND IT IS WITHIN BWI¿S POSSESSION. PLEASE PROVIDE A COMPLETE LIST OF ALL RELATED MEDICAL DEVICE REPORTING (MDR) ACCESS NUMBERS, AS WELL AS THE REASON FOR THEIR INCLUSION IN THE TREND. RESPONSE: IN THE LAST 24 MONTHS THERE HAVE BEEN TWO OTHER CARDIAC TAMPONADES HAVE BEEN REPORTED ASSOCIATED WITH THE PENTARAY NAV ECO CATHETER. THE 9673241-2014-00106, 9673241-2014-00441. WHAT OTHER COMPLAINTS YOU HAVE RECEIVED RELATED TO THIS DEVICE. RESPONSE: AS PREVIOUSLY STATED IN THE RESPONSE FOR QUESTION 5, IN THE LAST 24 MONTHS THERE HAVE BEEN TWO OTHER CARDIAC TAMPONADES HAVE BEEN REPORTED ASSOCIATED WITH THE PENTARAY NAV ECO CATHETER. WHAT ACTIONS HAVE BEEN TAKEN TO PREVENT SIMILAR EVENTS. RESPONSE: THERE HAVE BEEN THREE CARDIAC TAMPONADE EVENTS REPORTED WITHIN THE LAST 24 MONTHS UNDER THE PENTARAY NAV ECO CATHETER WHICH WERE THOUGHT TO BE POSSIBLY PROCEDURE RELATED PER TREATING PHYSICIANS. NO SIGNIFICANT TRENDS HAVE BEEN OBSERVED AND NO FURTHER ACTIONS HAVE BEEN REQUIRED AT THE MOMENT. PLEASE PROVIDE COPY OF DEVICE EVALUATION RELATED TO THIS EVENT. RESPONSE: PLEASE SEE ATTACHED PRODUCT ISSUE ANALYSIS REPORT. (B)(4)
EVALUATION SUMMARY. (B)(4). IT WAS REPORTED THAT A PATIENT, (B)(6), FEMALE, UNDERWENT A ATRIAL TACHYCARDIA LEFT (L-AT) PROCEDURE WITH A PENTARAY NAVIGATIONAL ECO CATHETER AND SUFFERED A CARDIAC TAMPONADE, WHICH REQUIRED A PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING THE PROCEDURE THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED IN WHICH 350 CC'S OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS STABILIZED AND TRANSFERRED FOR OVERNIGHT OBSERVATION. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE THE CATHETER WAS ALSO EVALUATED FOR CARTO 3. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. FINALLY AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER FAILED. CATHETER WAS DISSECTED AND IT WAS FOUND THAT THE IRRIGATION TUBING WAS FOLDED AT THE TIP TRANSITION AREA. 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 FAILED ON IRRIGATION TEST BUT THE ROOT CAUSE OF THE CARDIAC TAMPONADE REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.
IT WAS REPORTED THAT A PATIENT, (B)(6), FEMALE, UNDERWENT A ATRIAL TACHYCARDIA LEFT (L-AT) PROCEDURE WITH A PENTARAY NAVIGATIONAL ECO CATHETER AND SUFFERED A CARDIAC TAMPONADE, WHICH REQUIRED A PERICARDIOCENTESIS. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED IN WHICH 350 CC'S OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS STABILIZED AND TRANSFERRED FOR OVERNIGHT OBSERVATION. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. THE EVENT OCCURRED DURING THE MAPPING PHASE WHILE THE PHYSICIAN WAS USING A PENTARAY NAVIGATIONAL ECO CATHETER. A TRANSSEPTAL PUNCTURE HAD BEEN PERFORMED WITH A BRK 1 SX G407209 NEEDLE AND A ST. JUDE SL1 8.5 FRENCH SHEATH. THE PATIENT DID REQUIRE EXTENDED HOSPITALIZATION DUE TO THE EVENT. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS PROCEDURE RELATED. THE ACT VALUE WAS MAINTAINED AT 266 SECONDS. SETTINGS DURING THE EVENT INCLUDE: IRRIGATION FLOW SETTING OF 30 ML/MIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 737475 | PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER | CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY | MTD | BIOSENSE WEBSTER, INC. (JUAREZ) | D-1282-11-S | 17098800L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization| L| R |