CATH PKGD: WEDGE 6 FR 110 CM
Report
- Report Number
- 3010532612-2023-00717
- Event Type
- Malfunction
- Date Received
- December 11, 2023
- Date of Event
- November 28, 2023
- Report Date
- November 28, 2023
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DYG
- PMA / PMN Number
- K892530
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN#(B)(4) THE REPORTED COMPLAINT OF CATHETER DIFFICULT TO ADVANCE IN PATIENT IS NOT ABLE TO BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. THE REPORTED COMPLAINT WILL BE MONITORED FOR ANY DEVELOPING TRENDS. OTHER REMARKS: N/A CORRECTED DATA: N/A.
(B)(4). UDI RELATED DATA QUALITY UPDATES ONLY SECTION D.4.-UNIQUE IDENTIFIER (UDI)# CORRECTED TO (B)(6) OTHER REMARKS: N/A. CORRECTED DATA: N/A.
(B)(4). OTHER REMARKS: N/A. CORRECTED DATA: N/A.
THE REPORT STATES "TODAY DURING A PROCEDURE MY SURGEON OPENED A NEW BALLOON WEDGE PRESSURE CATHETER THAT WE JUST ORDERED LAST MONTH. A TIP DEFLECTOR 0.035" WIRE WAS INSERTED INTO THE 6F BWP (WHICH WE HAVE DONE BEFORE). THE TIP DEFLECTOR BECAME LODGED AND DIFFICULT TO MANEUVER WITHIN THE BWP. UPON INVESTIGATING THE BWP, THERE WAS A TEAR IN THE BWP AT THE TOP JUST BEFORE THE BIFURCATION OF THE BALLOON AND FLUSH PORTS. IT SEEMED THAT THE BWP RIPPED AND CREATED FRICTION MAKING IT DIFFICULT TO REMOVE THE TIP DEFLECTOR". ADDITIONAL INFORMATION RECEIVED STATES THAT THE TIP DEFLECTOR WAS ABLE TO BE SUCCESSFULLY REMOVED FROM THE PATIENT. A NEW CATHETER WAS INSERTED AT THE SAME INSERTION SITE. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "RECOVERED WELL FROM THE PROCEDURE".
THE REPORT STATES "TODAY DURING A PROCEDURE MY SURGEON OPENED A NEW BALLOON WEDGE PRESSURE CATHETER THAT WE JUST ORDERED LAST MONTH. A TIP DEFLECTOR 0.035" WIRE WAS INSERTED INTO THE 6F BWP (WHICH WE HAVE DONE BEFORE). THE TIP DEFLECTOR BECAME LODGED AND DIFFICULT TO MANEUVER WITHIN THE BWP. UPON INVESTIGATING THE BWP, THERE WAS A TEAR IN THE BWP AT THE TOP JUST BEFORE THE BIFURCATION OF THE BALLOON AND FLUSH PORTS. IT SEEMED THAT THE BWP RIPPED AND CREATED FRICTION MAKING IT DIFFICULT TO REMOVE THE TIP DEFLECTOR". ADDITIONAL INFORMATION RECEIVED STATES THAT THE TIP DEFLECTOR WAS ABLE TO BE SUCCESSFULLY REMOVED FROM THE PATIENT. A NEW CATHETER WAS INSERTED AT THE SAME INSERTION SITE. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "RECOVERED WELL FROM THE PROCEDURE".
THE REPORT STATES "TODAY DURING A PROCEDURE MY SURGEON OPENED A NEW BALLOON WEDGE PRESSURE CATHETER THAT WE JUST ORDERED LAST MONTH. A TIP DEFLECTOR 0.035" WIRE WAS INSERTED INTO THE 6F BWP (WHICH WE HAVE DONE BEFORE). THE TIP DEFLECTOR BECAME LODGED AND DIFFICULT TO MANEUVER WITHIN THE BWP. UPON INVESTIGATING THE BWP, THERE WAS A TEAR IN THE BWP AT THE TOP JUST BEFORE THE BIFURCATION OF THE BALLOON AND FLUSH PORTS. IT SEEMED THAT THE BWP RIPPED AND CREATED FRICTION MAKING IT DIFFICULT TO REMOVE THE TIP DEFLECTOR". ADDITIONAL INFORMATION RECEIVED STATES THAT THE TIP DEFLECTOR WAS ABLE TO BE SUCCESSFULLY REMOVED FROM THE PATIENT. A NEW CATHETER WAS INSERTED AT THE SAME INSERTION SITE. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "RECOVERED WELL FROM THE PROCEDURE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1771678 | CATH PKGD: WEDGE 6 FR 110 CM | CATHETER, FLOW DIRECTED | DYG | ARROW INTERNATIONAL LLC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | N/A.| N/A.| N/A. |