CLOSUREFAST MICRO INTRODUCER SHEATH SET 7FR/CH (2.3MM) X 7CM
Report
- Report Number
- 0001625425-2023-01210
- Event Type
- Malfunction
- Date Received
- October 2, 2023
- Date of Event
- September 8, 2023
- Report Date
- July 19, 2024
- Manufacturer
- ARGON MEDICAL DEVICES
- Product Code
- DRE
- UDI-DI
- 10884521140295
- PMA / PMN Number
- K780126
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
SAMPLE IS NOT AVAILABLE FOR RETURN. IMAGES WERE PROVIDED BY CUSTOMER FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.
UDI RELATED DATA QUALITY UPDATES ONLY CORRECTED INFORMATION TO PREVIOUS INFORMATION PROVIDED IN D.4. THE YEAR PORTION OF THE UDI WAS ENTERED INCORRECTLY.
A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO DEVIATIONS OR NON-CONFORMANCES WERE FOUND. NO SAMPLE WAS RETURNED TO ARGON FOR REVIEW. HOWEVER, IMAGES WERE PROVIDED BY THE CUSTOMER. THE IMAGE CONFIRMS THAT THE GUIDEWIRE IS BROKEN. CAPA CA-00040 HAS BEEN INITIATED TO ADDRESS THE BROKEN GUIDEWIRE ISSUE, AND THE CAPA WILL IDENTIFY THE SPECIFIC CAUSES AND CORRECTIVE ACTIONS TO BE TAKEN. AS PART OF THE CAPA PROCESS, A MDT/ARGON ROOT CAUSE INVESTIGATION TEAM WAS ASSEMBLED. AN EVALUATION OF THE INTERNAL RECORDS WAS PERFORMED, DISCUSSION WAS CONDUCTED WITH WIRE MANUFACTURER AND SUPPLIER ENGINEERING CHANGE ORDERS WERE ALSO REVIEWED FOR THE LAST FIVE YEARS. THERE WERE NO NON-CONFORMANCES FOUND BASED ON METALLURGY AND NO ENGINEERING CHANGES IDENTIFIED. A DEFINITE ROOT CAUSE WAS NOT IDENTIFIED FOR THIS FAILURE MODE AND NO IMMEDIATE CORRECTIONS WERE MADE DUE TO ABSENCE OF INITIAL ROOT CAUSE IDENTIFICATION. SEVERAL ACTION ITEMS HAVE BEEN PLANNED TO BE IMPLEMENTED TO ADDRESS THIS REPORTED EVENT. TENSILE TEST WILL BE IMPLEMENTED PER TEST METHOD, RETRAINING PROGRAM AND CERTIFICATION PROGRAM PLAN FOR POLISHING SILVER SOLDERING WILL BE PUT IN PLACE. IF NEW INFORMATION IS AVAILABLE IN FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED ACCORDINGLY.
UDI RELATED DATA QUALITY UPDATES ONLY. CORRECTED INFORMATION PROVIDED IN D.4.
PHYSICIAN INTENDED TO USE A MICRO INTRODUCER KIT DURING TREATMENT OF PATIENT¿S GREAT SAPHENOUS VEIN (GSV). THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. A GUIDEWIRE WAS USED FOR INSERTION OF THE CATHETER. TUMESCENT INFILTRATION WAS UTILIZED. LOCAL ANAESTHESIA WAS USED. HAND COMPRESSION WAS USED. IT IS REPORTED PATIENTS RIGHT GSV WAS TORTUOUS AND REQUIRED THREE ACCESS POINTS AFTER PHYSICIAN WAS UNABLE TO NAVIGATE WITH CATHETER OR WIRE. ACCESS WAS OBTAINED VIA DISTAL CALF, BELOW KNEE AND MID-THIGH. MID-THIGH TO SFJ WAS TREATED ACCORDING TO IFU. PHYSICIAN THEN ATTEMPTED TO INSERT CATHETER INTO ACCESS SITE BELOW KNEE AND WHILE ATTEMPTING TO NAVIGATE GSV PULLED OUT THE INTRODUCER LOOSENING ACCESS. INTRODUCER WAS RE-PREPPED, AND ACCESS WAS OBTAINED AGAIN IN THE SAME LOCATION, WHEN REMOVING THE DILATOR AND WIRE IT WAS NOTICED THAT A PORTION OF THE ACCESS WIRE WAS NO LONGER ATTACHED. WIRE WAS ATTEMPTED TO BE LOCATED WITH ULTRASOUND BUT WAS UNABLE TO BE SEEN. INTRODUCER WAS REMOVED AND FLUSHED BUT WIRE WAS STILL NOT SEEN. PROCEDURE WAS STOPPED AFTER IT WAS NOTICED THAT A PORTION OF THE WIRE WAS MISSING UPON REMOVAL OF ACCESS WIRE. AN X-RAY WAS ORDERED POST PROCEDURE, AND PORTION OF WIRE WAS NOTED REMAINING IN GSV AT KNEE. NEEDLE FROM MIS-7F07 KIT WAS NOT USED FOR ACCESS, PHYSICIAN PREFERS RADIAL ACCESS NEEDLE. A NON-MEDTRONIC RADIAL ACCESS NEEDLE (TERUMO 21G 35MM) WAS USED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.
PHYSICIAN INTENDED TO USE A MICRO INTRODUCER KIT DURING TREATMENT OF PATIENT¿S GREAT SAPHENOUS VEIN (GSV). THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. A GUIDEWIRE WAS USED FOR INSERTION OF THE CATHETER. TUMESCENT INFILTRATION WAS UTILIZED. LOCAL ANAESTHESIA WAS USED. HAND COMPRESSION WAS USED. IT IS REPORTED PATIENTS RIGHT GSV WAS TORTUOUS AND REQUIRED THREE ACCESS POINTS AFTER PHYSICIAN WAS UNABLE TO NAVIGATE WITH CATHETER OR WIRE. ACCESS WAS OBTAINED VIA DISTAL CALF, BELOW KNEE AND MID-THIGH. MID-THIGH TO SFJ WAS TREATED ACCORDING TO IFU. PHYSICIAN THEN ATTEMPTED TO INSERT CATHETER INTO ACCESS SITE BELOW KNEE AND WHILE ATTEMPTING TO NAVIGATE GSV PULLED OUT THE INTRODUCER LOOSENING ACCESS. INTRODUCER WAS RE-PREPPED, AND ACCESS WAS OBTAINED AGAIN IN THE SAME LOCATION, WHEN REMOVING THE DILATOR AND WIRE IT WAS NOTICED THAT A PORTION OF THE ACCESS WIRE WAS NO LONGER ATTACHED. WIRE WAS ATTEMPTED TO BE LOCATED WITH ULTRASOUND BUT WAS UNABLE TO BE SEEN. INTRODUCER WAS REMOVED AND FLUSHED BUT WIRE WAS STILL NOT SEEN. PROCEDURE WAS STOPPED AFTER IT WAS NOTICED THAT A PORTION OF THE WIRE WAS MISSING UPON REMOVAL OF ACCESS WIRE. AN X-RAY WAS ORDERED POST PROCEDURE, AND PORTION OF WIRE WAS NOTED REMAINING IN GSV AT KNEE. NEEDLE FROM MIS-7F07 KIT WAS NOT USED FOR ACCESS, PHYSICIAN PREFERS RADIAL ACCESS NEEDLE. A NON-MEDTRONIC RADIAL ACCESS NEEDLE (TERUMO 21G 35MM) WAS USED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 467499 | CLOSUREFAST MICRO INTRODUCER SHEATH SET 7FR/CH (2.3MM) X 7CM | CLOSUREFAST MICRO INTRODUCER SHEATH SET | DRE | ARGON MEDICAL DEVICES | MIS-7F07 | 11489176 | 10884521140295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| R |