EMPIRA NC RX PTCA DILATATION CATHETER
Report
- Report Number
- 3004036480-2018-00002
- Event Type
- Malfunction
- Date Received
- September 5, 2018
- Date of Event
- August 6, 2018
- Report Date
- October 24, 2018
- Manufacturer
- CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL
- Product Code
- LOX
- PMA / PMN Number
- K110133
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
THE OBSERVATIONS MADE DURING THE ANALYSIS FOUND THE FOLLOWING: THE CATHETER WAS RETURNED IN POOR CONDITION. THE CATHETER WAS RETURNED WITHOUT THE BALLOON COVER. THE PACKING STYLET WAS NOT RETURNED WITH THE DEVICE. THE CATHETER WAS RETURNED IN FOUR SEPARATE PIECES THE BALLOON, DISTAL TIP, MARKERBANDS OR RX PORT SECTION WERE NOT RETURNED FOR ANALYSIS. THE BURST FAILURE MODE OCCURRED ON THE DISTAL SHAFT. BASED ON THE INVESTIGATION CONDUCTED THE AS REPORTED COMPLAINT COULD BE CONFIRMED. THE DAMAGE IDENTIFIED (DISTAL SHAFT BURST WITH BALLOON SEPARATION) CORRESPONDS WITH THE DAMAGE ASSOCIATED WITH EMPIRA - BALLOON - DEFLATION DIFFICULTY AND EMPIRA - BALLOON - BURST-AT/BELOW RBP. FOLLOWING INVESTIGATION RESULT THE COMPLAINT ANALYSED CLASSIFICATION IS ASSIGNED AS PRIMARY ANALYSED CLASSIFICATION AS EMPIRA - DISTAL SHAFT - LEAK AND AS SECONDARY ANALYSED CLASSIFICATION AS EMPIRA - DISTAL SHAFT - SHAFT SEPARATION. BASED ON A REVIEW OF THE RISK DOCUMENTATION AND INFORMATION AVAILABLE, NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE EMPIRA DEVICE. THERE IS NO INDICATION OF A POTENTIAL PROCESSING OR DESIGN FAILURE ASSOCIATED WITH THIS COMPLAINT. THERE WWERE NO CAPA, (CORRECTIVE AND PREVENTATIVE ACTION), MRR (MATERIAL REVIEW REPORT) OR DEVIATION BEING GENERATED FOR THIS LOT, CE1014027 DURING THE MANUFACTURING PROCESS THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. AS OF 23 OCTOBER 2018, WHEN THE REVIEW WAS COMPLETED, THERE WAS NO OTHER COMPLAINT ASSOCIATED WITH LOT NUMBER CE1014027, FOR THE AS REPORTED FAILURE EMPIRA - BALLOON - DEFLATION DIFFICULTY. FROM THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE PRESENT TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. THE COMPLAINT REPORTED HAS BEEN ASSIGNED A PRIMARY AS REPORTED CLASSIFICATION OF EMPIRA - BALLOON - DEFLATION DIFFICULTY AND A SECONDARY REPORTED CLASSIFICATION DIFFICULTY AND BALLOON - BURST-AT/BELOW RBP. FOLLOWING COMPLETION OF CREGANNA MEDICAL INFORMATION REVIEW, THE ANALYSED CLASSIFICATION HAS BEEN ASSIGNED AS PRIMARY CODE: EMPIRA - DISTAL SHAFT - LEAK/BURST AND A SECONDARY CODE: EMPIRA - DISTAL SHAFT - SHAFT SEPARATION. BASED ON THE COMPLAINT REVIEW AND THE EVENT DESCRIPTION FOR THIS COMPLAINT, THE COMPLAINT COULD BE CONFIRMED. THERE IS NO EVIDENCE OF A POTENTIAL PROCESSING OR DESIGN FAILURE ASSOCIATED WITH THIS COMPLAINT, NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE EMPIRA DEVICE. BASED ON THE COMPLAINT REVIEW AND THE EVENT DESCRIPTION THE MOST PROBABLE ROOT-CAUSE CLASSIFICATION ASSIGNED TO THIS COMPLAINT IS 'UNDETERMINABLE. THE DEFINITION OF 'UNDETERMINABLE' PER CREGANNA MEDICAL PROCEDURE IS: 'REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE.' THE COMPLAINT IS REPORTABLE AND HAS BEEN ESCALATED TO QUALITY MANAGEMENT TEAM. BASED ON THE ABOVE CONCLUSION, NO FURTHER ESCALATION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME. CREGANNA MEDICAL WILL CONTINUE TO MONITOR FOR THESE COMPLAINT TYPES.
PRODUCT WAS NOT RETURNED FOR REVIEW AT THE TIME OF THIS REPORT BEING COMPLETED. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AND EXAMINATION. IT WAS THEREFORE NOT POSSIBLE TO CARRY OUT ANY DIMENSIONAL, FUNCTIONAL, VISUAL OR MICROSCOPIC EXAMINATION ON THE DEVICE. THEREFORE, THE AS REPORTED CLASSIFICATIONS OF (EMPIRA - BALLOON - DEFLATION DIFFICULTY AND BALLOON - BURST-AT/BELOW RBP) CANNOT BE CONFIRMED. BASED ON A REVIEW OF THE RISK DOCUMENTATION AND INFORMATION AVAILABLE, NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE EMPIRA DEVICE. THERE IS NO INDICATION OF A POTENTIAL PROCESSING OR DESIGN FAILURE ASSOCIATED WITH THIS COMPLAINT. THERE WAS NOT ANY CAPA, (CORRECTIVE AND PREVENTATIVE ACTION), MRR (MATERIAL REVIEW REPORT) OR DEVIATION BEING GENERATED FOR THIS LOT, CE1014027 DURING THE MANUFACTURING PROCESS THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. AS OF 4 SEPTEMBER 2018, WHEN THE REVIEW WAS COMPLETED, THERE WAS NO OTHER COMPLAINT ASSOCIATED WITH LOT NUMBER CE1014027, FOR THE AS REPORTED FAILURE EMPIRA - BALLOON - DEFLATION DIFFICULTY. FROM THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE PRESENT TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. THE COMPLAINT REPORTED HAS BEEN ASSIGNED A PRIMARY AS REPORTED CLASSIFICATION OF EMPIRA - BALLOON - DEFLATION DIFFICULTY AND A SECONDARY REPORTED CLASSIFICATION DIFFICULTY AND BALLOON - BURST-AT/BELOW RBP. FOLLOWING COMPLETION OF CREGANNA MEDICAL INFORMATION REVIEW, THE ANALYSED CLASSIFICATION HAS BEEN ASSIGNED AS EMPIRA - PRODUCT NOT RETURNED - COMPLAINT UNABLE TO CONFIRM. PRODUCT WAS NOT RETURNED FOR REVIEW AT THE TIME OF THIS REPORT BEING COMPLETED. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AND EXAMINATION. IT WAS THEREFORE NOT POSSIBLE TO CARRY OUT ANY DIMENSIONAL, FUNCTIONAL, VISUAL OR MICROSCOPIC EXAMINATION ON THE DEVICE. THEREFORE, THE AS REPORTED CLASSIFICATIONS (EMPIRA - BALLOON - DEFLATION DIFFICULTY AND BALLOON - BURST-AT/BELOW RBP) CANNOT BE DETERMINED. THE COMPLAINT IS REPORTABLE, THEREFORE IT HAS BEEN ESCALATED TO QUALITY MANAGEMENT TEAM. THE PROBABLE ROOT-CAUSE CLASSIFICATION ASSIGNED TO THIS COMPLAINT IS 'UNDETERMINABLE. THE DEFINITION OF 'UNDETERMINABLE' IS: 'REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE.' BASED ON THE ABOVE CONCLUSION, NO FURTHER ESCALATION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME. CREGANNA MEDICAL WILL CONTINUE TO MONITOR FOR THESE COMPLAINT TYPES.
AS REPORTED,THE BALLOON CANNOT DEFLATE NORMALLY, AND CAN NOT RETRACT THE SHEATH TUBE, AFTER 18ATM PRESSURE THE BALLOON WAS BURST, WITH SURGICAL TREATMENT TO REMOVE.
AS REPORTED,THE BALLOON CANNOT DEFLATE NORMALLY, AND CAN NOT RETRACT THE SHEATH TUBE, AFTER 18ATM PRESSURE THE BALLOON WAS BURST, WITH SURGICAL TREATMENT TO REMOVE.
PRODUCT WAS NOT RETURNED FOR REVIEW AT THE TIME OF THIS REPORT BEING COMPLETED. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AND EXAMINATION. IT WAS THEREFORE NOT POSSIBLE TO CARRY OUT ANY DIMENSIONAL, FUNCTIONAL, VISUAL OR MICROSCOPIC EXAMINATION ON THE DEVICE. THEREFORE, THE AS REPORTED CLASSIFICATIONS OF (EMPIRA - BALLOON - DEFLATION DIFFICULTY AND BALLOON - BURST-AT/BELOW RBP) CANNOT BE CONFIRMED. BASED ON A REVIEW OF THE RISK DOCUMENTATION AND INFORMATION AVAILABLE, NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE EMPIRA DEVICE. THERE IS NO INDICATION OF A POTENTIAL PROCESSING OR DESIGN FAILURE ASSOCIATED WITH THIS COMPLAINT. THERE WAS NOT ANY CAPA, (CORRECTIVE AND PREVENTATIVE ACTION), MRR (MATERIAL REVIEW REPORT) OR DEVIATION BEING GENERATED FOR THIS LOT, CE1014027 DURING THE MANUFACTURING PROCESS THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. AS OF 4 SEPTEMBER 2018, WHEN THE REVIEW WAS COMPLETED, THERE WAS NO OTHER COMPLAINT ASSOCIATED WITH LOT NUMBER CE1014027, FOR THE AS REPORTED FAILURE EMPIRA - BALLOON - DEFLATION DIFFICULTY. FROM THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE PRESENT TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. THE COMPLAINT REPORTED HAS BEEN ASSIGNED A PRIMARY AS REPORTED CLASSIFICATION OF EMPIRA - BALLOON - DEFLATION DIFFICULTY AND A SECONDARY REPORTED CLASSIFICATION DIFFICULTY AND BALLOON - BURST-AT/BELOW RBP. FOLLOWING COMPLETION OF CREGANNA MEDICAL INFORMATION REVIEW, THE ANALYSED CLASSIFICATION HAS BEEN ASSIGNED AS EMPIRA - PRODUCT NOT RETURNED - COMPLAINT UNABLE TO CONFIRM. PRODUCT WAS NOT RETURNED FOR REVIEW AT THE TIME OF THIS REPORT BEING COMPLETED. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AND EXAMINATION. IT WAS THEREFORE NOT POSSIBLE TO CARRY OUT ANY DIMENSIONAL, FUNCTIONAL, VISUAL OR MICROSCOPIC EXAMINATION ON THE DEVICE. THEREFORE, THE AS REPORTED CLASSIFICATIONS (EMPIRA - BALLOON - DEFLATION DIFFICULTY AND BALLOON - BURST-AT/BELOW RBP) CANNOT BE DETERMINED. THE COMPLAINT IS REPORTABLE, THEREFORE IT HAS BEEN ESCALATED TO QUALITY MANAGEMENT TEAM. THE PROBABLE ROOT-CAUSE CLASSIFICATION ASSIGNED TO THIS COMPLAINT IS 'UNDETERMINABLE. THE DEFINITION OF 'UNDETERMINABLE' IS: 'REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE.' BASED ON THE ABOVE CONCLUSION, NO FURTHER ESCALATION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME. CREGANNA MEDICAL WILL CONTINUE TO MONITOR FOR THESE COMPLAINT TYPES.
AS REPORTED, THE BALLOON CANNOT DEFLATE NORMALLY, AND CAN NOT RETRACT THE SHEATH TUBE, AFTER 18ATM PRESSURE THE BALLOON WAS BURST, WITH SURGICAL TREATMENT TO REMOVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 689187 | EMPIRA NC RX PTCA DILATATION CATHETER | PTCA CATHETER | LOX | CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL | 75R12350N | CE1014027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |