DLP AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA WITH VENT LINE
Report
- Report Number
- 2184009-2024-00192
- Event Type
- Malfunction
- Date Received
- April 18, 2024
- Date of Event
- April 13, 2024
- Report Date
- November 26, 2024
- Manufacturer
- PERFUSION SYSTEMS
- Product Code
- DWF
- PMA / PMN Number
- K810548
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS THE MALE LUER STEM OF NEEDLE INTRODUCER APPEARS TO HAVE BEEN INADVERTENTLY BONDED TO THE FEMALE LUER DURING ASSEMBLY AND WHEN IT WAS REMOVED THE LUER CRACKED/SPLIT. REASON FOR RETURN WAS CONFIRMED. ADDITIONAL INFORMATION B5. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE CUSTOMER CANNOT REMEMBER THE EXACT DETAILS FROM THE EVENT BUT THEIR NORMAL PROTOCOL IS TO WET THE CANNULA IN HARTMAN¿S SOLUTION AT ROOM TEMPERATURE. THE CUSTOMER STATED THERE WAS NO OBVIOUS DAMAGE TO THE CANNULA. THE CANNULA CAME IN A PROCEDURE PACK PROVIDED BY A PACK SUPPLIER WHO PUT THE MEDTRONIC CANNULA INSIDE THEIR PROCEDURE PACK. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP AORTIC ROOT CANNULA WITH VENT LINE, IT WAS REPORTED THAT ONCE THE PATIENT HAD BEEN CANNULATED WITH THE DEVICE THE CUSTOMER COULD NOT REMOVE THE NEEDLE FROM THE CANNULA BODY/LUER CONNECTOR. THERE WAS MINIMAL BLOOD LOSS AND A DELAY OF APPROXIMATELY FIVE MINUTES TO THE PROCEDURE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513297 | DLP AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA WITH VENT LINE | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO | DWF | PERFUSION SYSTEMS | 20014 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |