TELESCOPE GUIDE EXTENSION CATHETER
Report
- Report Number
- 9612164-2022-03610
- Event Type
- Malfunction
- Date Received
- September 30, 2022
- Date of Event
- April 7, 2021
- Report Date
- September 30, 2022
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- DQY
- PMA / PMN Number
- K183353
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT ANALYSIS SUMMARY: THE DEVICE RETURNED WITH THE MATERIAL OF THE PROXIMAL END OF THE ON-RAMP APPEARING NARROWED. NO STENT RETURNED WITHIN THE LUMEN OF THE TELESCOPE GEC. NO DEFORMATION WAS EVIDENT TO THE ENTRY PORT. SLIGHT DEFORMATION EVIDENT TO THE DISTAL TIP. THE INNER LUMEN OF THE TELESCOPE GEC WAS VERIFIED TO 0.0540 INCHES BY PASSING A LUMEN PATENCY BALL THROUGH THE LUMEN OF THE DEVICE, NO RESISTANCE WAS ENCOUNTERED. NO OTHER DEFORMATION TO THE REMAINDER OF THE DEVICE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE 6 FRENCH TELESCOPE GUIDE EXTENSION CATHETER (GEC) TO TREAT A LESION LOCATED WITH A 90 DEGREE BEND IN THE LAD (CASS#6). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING AND PREPPEDPER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. SOME RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS STATED THAT THERE WAS SOME RESISTANCE WHEN THE NON-MEDTRONIC STENT WAS PASSING THROUGH THE EXIT PORT. IT WAS REPORTED THAT A MATING DEVICE ISSUE OCCURRED. IT WAS STATED THAT A NON-MEDTRONIC STENT WAS ATTEMPTED TO BE DELIVERED USING THE TELESCOPE GEC, HOWEVER THE STENT DID NOT PASS THROUGH THE LESION, AND IT FELL OUT IN THE TELESCOPE. IT WAS INDICATED THAT THE STENT DISLODGED IN THE CORONARY ARTERY. THE NON-MEDTRONIC STENT OF A DIFFERENT LENGTH WAS ATTEMPTED TO BE USED, HOWEVER THE STENT FAILED TO CROSS THE LESION AND IT FELL OFF WITHIN THE TELESCOPE AGAIN. ANOTHER NON-MEDTRONIC STENT AND GUIDE WERE USED TO PASS THROUGH THE LESION, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2647783 | TELESCOPE GUIDE EXTENSION CATHETER | CATHETER, PERCUTANEOUS | DQY | MEDTRONIC IRELAND | 0010457644 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |