ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE
Report
- Report Number
- 3001845648-2023-00534
- Event Type
- Malfunction
- Date Received
- July 5, 2023
- Date of Event
- June 6, 2023
- Report Date
- January 8, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 10827002492575
- PMA / PMN Number
- K030618
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
COMMON NAME: BSP, PMA/510(K) #: K030618. DEVICE EVALUATION: (B)(4) UNIT OF LOT C2030110 OF ECHO-20-CPN WAS RETURNED OPENED NOT IN ITS ORIGINAL PACKAGING. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 03 AUGUST 2023 AND A LAB RE-EVALUATION ON 16 OCTOBER 2023. THE LAB EVALUATION NOTES AND LAB ATTENDANCE CAN BE VIEWED IN THE ¿RETURNED PRODUCT ¿ NOTES¿ SECTION. THE NEEDLE HANDLE WAS DETACHED FROM THE REST OF THE DEVICE. A KINK BELOW THE SHEATH EXTENDER AND ANOTHER SEVERE KINK JUST BELOW THE NEEDLE HANDLE WAS OBSERVED. THE DISTAL END OF THE SHEATH WAS OBSERVED TO BE DAMAGED/CRUMPLED. THE LOCKING RING AND ITS THUMBSCREW WERE RETURNED SEPARATELY FROM THE DEVICE. NEEDLE REMOVED FROM THE DEVICE AND BREAK OBSERVED APPROXIMATELY 76CM FROM NEEDLE HUB. MLLA EXAMINED AND NO ISSUE OBSERVED. MANUFACTURING RECORDS PRIOR TO DISTRIBUTION, ALL ECHO-20-CPN DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-20-CPN OF LOT NUMBER C2030110 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0039, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE FOR ANY DAMAGE: "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE" AND "ENSURE THE STYLET IS FULLY INSERTED WHEN ADVANCING THE NEEDLE INTO THE TARGET SITE". THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IN RELATION TO THE USE OF THE STYLET (IFU0039). IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO USER ERROR AS THE STYLET SHOULD NOT BE PARTIALLY (OR FULLY) REMOVED PRIOR TO ADVANCEMENT OF THE NEEDLE INTO INTENDED TARGETED SITE. AS PER ANSWER TO ONE OF THE STANDARD QUESTIONS THE STYLET WAS FULLY REMOVED WHICH MAY HAVE MEANT THAT THE USER PUT ADDITIONAL PRESSURE ON THE DEVICE POTENTIALLY LEADING TO THE NEEDLE HANDLE DETACHING FROM THE DEVICE. IT IS LIKELY THAT THE DIFFERENT NEEDLE KINKS AND NEEDLE BREAK OBSERVED DURING THE LAB EVALUATION OCCURRED DURING THE TRANSPORT RETURNS PROCESS AS IT WAS CONFIRMED THAT THE NEEDLE WAS ABLE TO FULLY RETRACT INTO THE SHEATH BEFORE REMOVING THE DEVICE FROM THE PATIENT. IT IS ALSO LIKELY THAT THE ISSUES OBSERVED DURING THE LAB EVALUATION WITH THE LOCKING RING, THUMBSCREW AND DISTAL END OF SHEATH WOULD HAVE OCCURRED DURING THE TRANSPORT RETURNS PROCESS AS THE DEVICE WAS RETURNED TO CIRL NOT IN ITS ORIGINAL PACKAGING BUT IN A PLASTIC BAG. SUMMARY COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.
PMA 510K #K030618. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 08-JAN-2024.
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: UPON REMOVING THE DEVICE FROM THE SCOPE IT FELL APART. WHEN UNSCREWING FROM THE PORT IT FELL APART. 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 5. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. 6. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. ECHO 4.1 FOR ALL COMPLAINTS, ASK: ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A. IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END (PROXIMAL END) OR PATIENT END (DISTAL END))? N/A. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? NO. PLEASE SPECIFY IF YES. IF THE DEVICE WAS KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? N/A. IF THE DEVICE IS A PROCORE NEEDLE, IS THE DEVICE DAMAGE LOCATED AT THE NOTCH / CORE TRAP? N/A. IF NO, PLEASE SPECIFY WHERE THE DAMAGE IS LOCATED: WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? NO. WAS THE DEVICE USED IN A TORTUOUS POSITION? NO. WAS PUNCTURE OF THE TARGET SITE DIFFICULT? NO. PLEASE DESCRIBE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS ETC.). CELIAC GANGLIA. IF THE LUNGS, WHICH LYMPH NODE WAS BEING TARGETED? E.G. 4R, 11R, 12L ETC. N/A. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. NOT SPECIFIED IN MD NOTE IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? NEW CPN NEEDLE. WAS THE DEVICE DAMAGED IN PACKAGING PRIOR TO REMOVAL? NO. WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? NO. WAS FORCE REQUIRED TO REMOVE THE DEVICE? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO. WHAT INTERVENTION (IF ANY) WAS REQUIRED? N/A. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINKS, BENDS, BREAKS ETC.)? NO. IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED. WHAT IS THE SCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? ENDOSONOSCOPE, OLYMPUS GIF UCT 180. WAS RESISTANCE FELT WHILE INSERTING THE DEVICE THROUGH THE SCOPE? NO. WAS THE SCOPE RECENTLY SERVICED / REPAIRED? NO. WHEN WAS THE ISSUED WITH THE PRODUCT NOTED? ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RETRACTION? RETRACTION. WAS THE SYRINGE USED DURING THE PROCEDURE, AFTER THE STYLET WAS REMOVED? YES. WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? YES. WAS IT POSSIBLE TO FULLY RETRACT THE NEEDLE INTO THE SHEATH BEFORE REMOVING THE DEVICE FROM THE PATIENT? YES. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? NO. WAS THE STYLET PARTIALLY REMOVED WHEN ADVANCING THE NEEDLE INTO THE TARGET SITE? N/A, YES, NO FULLY REMOVED. HOW MANY SAMPLES WERE OBTAINED (PASSES COMPLETED) WITH THIS NEEDLE? 0, ZERO. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? NO. IF YES, PLEASE SPECIFY: WAS THERE DIFFICULTY LOCKING THE SHEATH (OR NEEDLE) IN PLACE OR SLIPPING EXPERIENCED DURING USE? NO. WAS THERE DIFFICULTY IN ATTACHING OR DETACHING THE DEVICE TO THE ACCESSORY CHANNEL PORT ON THE SCOPE? YES- DETACHING; NEEDLE DEVICE CAME APART. WHEN THE NEEDLE TIP WAS ADVANCED INTO THE TARGET SITE WAS THE DISTAL SCOPE POSITION ADJUSTED SO AS TO STRAIN OR FLEX THE NEEDLE? NO. IF AN EBUS PROCEDURE DID THE NEEDLE TIP HIT THE CARTILAGE RINGS OF THE TRACHEA? N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1930469 | ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | C2030110 | 10827002492575 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male |