ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2023-00034
- Event Type
- Injury
- Date Received
- January 17, 2023
- Date of Event
- December 5, 2022
- Report Date
- June 15, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 10827002342795
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA 510K #K210476; DEVICE EVALUATION; 2 UNITS OF LOT C1968098 OF ECHO-HD-22-EBUS-P-C WAS RETURNED OPENED IN THEIR ORIGINAL PACKAGING. WHILE TWO DEVICES WERE RETURNED ONLY ONE OF THE DEVICES RELATED TO THE SPECIFIC COMPLAINT ISSUE AS THE CARE TEAM WERE UNABLE TO SELECT WHICH OF THE DEVICES WAS RELATED TO THE COMPLAINT THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION PROXIMAL KINK BELOW SHEATH EXTENDER OBSERVED ON BOTH DEVICES. THE DISTAL END AND TIP OF BOTH NEEDLES WERE EXAMINED, AND NO ISSUE OBSERVED. THE DISTAL END AND TIP OF BOTH STYLETS WERE EXAMINED, AND NO ISSUE OBSERVED. THROUGH THE INVESTIGATION IT WAS ESTABLISHED THAT THE PROXIMAL KINKS WHICH WERE OBSERVED DURING THE LAB EVALUATION MOST LIKELY CAME ABOUT AS A RESULT OF THE TRANSPORT RETURNS PROCESS. THROUGH THE INVESTIGATION AND LAB EVALUATIONS CARRIED OUT IT WAS ALSO ESTABLISHED THAT THE SMALL MILLIMETRIC PIECE OF METAL THAT WAS OBSERVED IN THE PATIENT¿S TRACHEA IS MOST LIKELY TO HAVE COME FROM THE SCOPE CHANNEL OR SOMEWHERE ELSE AND NOT THE COMPLAINT DEVICE. MANUFACTURING RECORDS. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-P-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-P-C OF LOT NUMBER C1968098 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, IFU0110 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO; "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE¿. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0110). IMAGE REVIEW. AN IMAGE WAS PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THIS WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER. 1. A CURVILINEAR FRAGMENT NEAR THE BIOPSY SITE IS CONFIRMED. THE SHAPE AND COLOR ARE CONSISTENT WITH A METALLIC FRAGMENT. THE MOST LIKELY SOURCE WAS A BRAID OF THE SHEATH SHAVED FROM THE SHEATH INSIDE BY THE NEEDLE. THIS COULD BE UNDETECTABLE DURING INSPECTION OF THE SHEATH¿S OUTSIDE. 2. THE EVENT REPORTEDLY OCCURRED DURING NEEDLE REMOVAL WITH THE SHEATH LEFT IN PLACE. THIS MANEUVER IS OUTSIDE THE IFU BECAUSE IT WOULD HAVE REQUIRED REMOVING THE NEEDLE FROM THE END OF THE HANDLE. THE IFU ONLY ALLOWS FOR NEEDLE/SHEATH REMOVAL AT THE HANDLE BASE. THIS WOULD HAVE INCREASED THE LIKELIHOOD OF THE NEEDLE SHAVING A WIRE BRAID AND MAY HAVE ALSO CAUSED THE REPORTED SHEATH TWIST. 3. INABILITY TO FIND THE FRAGMENT COULD HAVE BEEN THE RESULT OF DISTAL MIGRATION HOWEVER PARTICULARLY GIVEN ITS SMALL SIZE, IT COULD HAVE BEEN SUCTIONED OR EXPECTORATED WITHOUT BEING NOTICED. THROUGH THE INVESTIGATION IT WAS ESTABLISHED THAT THE STATEMENTS FROM THE COMPLAINT DESCRIPTION ¿WHEN I WANTED TO TAKE THE NEEDLE OUT OF ITS GUIDE¿ AND FROM THE COMPLAINT FORM ¿DIFFICULTY IN TAKING OUT THE NEEDLE¿ REFERS TO ADVANCING THE NEEDLE OUT OF THE SHEATH TO THE TARGET LOCATION. THIS WOULD THEREFORE DISCOUNT THE SECOND FINDING ABOVE FROM THE IMAGE REVIEW. IT WAS ALSO ESTABLISHED THROUGH THE INVESTIGATION THAT THE SMALL METALLIC FRAGMENT SEEN IN THE IMAGE COULD NOT HAVE BEEN FROM THE SHEATH AS THIS IS MADE OF PLASTIC MATERIAL AND POTENTIALLY THE FRAGMENT MIGHT BE FROM THE SCOPE CHANNEL OR SOMETHING ELSE ROOT CAUSE ANALYSIS; A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO DIFFICULT TARGET SITE AND TORTUOUS POSITION AS PER ADDITIONAL INFORMATION. THIS COULD HAVE LED TO THE NEEDLE NOT ADVANCING PROPERLY OUT OF THE SHEATH (JUMP IN THE DEVICE WHICH THE USER FELT) LEADING TO POTENTIALLY HITTING SOME PART OF THE SCOPE AND CAUSING A SMALL PIECE TO OF THE SCOPE CHANNEL TO COME OFF. IT IS ALSO POSSIBLE THE ROOT CAUSE COULD BE ATTRIBUTED TO POSITIONING OF THE DEVICE PREVENTING THE NEEDLE EXITING PROPERLY FROM THE SHEATH OR THE DEVICE POSSIBLY BEING HELD AT AN ANGLE WHEN TRYING TO ADVANCE THE NEEDLE OR IN AN UNFAVORABLE POSITION. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE CONSEQUENCES WERE UNFORESEEN EXAMINATIONS AND MEDICAL ACTS, A BRONCHIAL FIBROSCOPY HAVING BEEN SET UP TO RECOVER THE SPLINTER, WITHOUT SUCCESS. PROLONGATION OF ANESTHESIA. DURING THE BRONCHIAL FIBROSCOPY THE MILIMETRIC METALLIC SHINE HAD DISAPPEARED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.
PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K)#: K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION FROM THE LAB EVALUATION ON 13-MAR-2023.
SUPPLEMENTAL FOLLOW-UP MDR REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON THE 15 JUNE 2023
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION FROM THE LAB EVALUATION ON THE 23 JAN 2023.
SUPPLEMENTAL FOLLOW-UP MDR REPORT IS BEING SUBMITTED DUE TO IMAGE REVIEW BEING COMPLETED ON 28-MAR-2023.
WHEN I WANTED TO TAKE THE NEEDLE OUT OF ITS GUIDE AFTER HAVING POSITIONED IT IN THE ENDOSCOPE, CUSTOMER NOTICED A JUMP WHICH PREVENTED ME FROM TAKING THE NEEDLE OUT GRADUALLY, ONLY AFTER A DEFINITE PULL. SECONDARY, A SMALL MILLIMETRIC SHRAPNEL CAME OUT IN THE TRACHEA, WITHOUT ME BEING ABLE TO RECOVER IT. THE CONSEQUENCES WERE UNFORESEEN EXAMINATIONS AND MEDICAL ACTS, A BRONCHIAL FIBROSCOPY HAVING BEEN SET UP TO RECOVER THE SPLINTER, WITHOUT SUCCESS. "AS PER CC FORM": FIRST PUNCTURE WITH A NEEDLE FROM THE SAME BATCH. NO PROBLEM. A FEW PUNCTURES DONE. CHANGE OF NEEDLE FOR OTHER PUNCTURES ALWAYS ON THE SAME PATIENT. INTRODUCTION OF THE SHEATH INTO THE WORKING CHANNEL. AT THE TIME OF TAKING OUT THE NEEDLE A JUMP IS FELT, DIFFICULTY IN TAKING OUT THE NEEDLE BUT PUNCTURE ALL THE SAME. WHEN REMOVING THE NEEDLE, VISUAL SIGHT OF A SMALL PIECE OF METAL. A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT¿S BODY. THE SMALL PIECE OF METAL COULD NOT BE REMOVED. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. PROLONGATION OF ANESTHESIA. DURING THE BRONCHIAL FIBROSCOPY THE MILIMETRIC METALLIC SHINE HAD DISAPPEARED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. 1. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? YES PHOTO (SEND BY MAIL). 2. 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)? NO. 3. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? NO. PLEASE SPECIFY IF YES. 4. IF THE DEVICE WAS KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? NO. 5. IF THE DEVICE IS A PROCORE NEEDLE, IS THE DEVICE DAMAGE LOCATED AT THE NOTCH / CORE TRAP? NO. IF NO, PLEASE SPECIFY WHERE THE DAMAGE IS LOCATED: 6. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? YES. 7. WAS THE DEVICE USED IN A TORTUOUS POSITION? YES. 8. WAS PUNCTURE OF THE TARGET SITE DIFFICULT? NO. 9. PLEASE DESCRIBE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE BRONCHUS A. IF THE LUNGS, WHICH LYMPH NODE WAS BEING TARGETED? NO INFORMATION FOR THE PUNCTURE SITE. 10. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. 11. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? SEE THE FORM. 12. WAS THE DEVICE DAMAGED IN PACKAGING PRIOR TO REMOVAL? NO. 13. WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? NO. 14. WAS FORCE REQUIRED TO REMOVE THE DEVICE? NO. 15. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? YES SEE THE FORM. 16. WHAT INTERVENTION (IF ANY) WAS REQUIRED? YES SEE THE FORM. 17. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? SAME PROCEDURE. 18. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINKS, BENDS, BREAKS ETC.)? YES SLIGHTLY TWISTED NEEDLE SHEATH. 19. IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED. SLIGHTLY TWISTED NEEDLE SHEATH. 20. WHAT IS THE SCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? SEE THE FORM. 21. WAS RESISTANCE FELT WHILE INSERTING THE DEVICE THROUGH THE SCOPE? NO. 22. WAS THE SCOPE RECENTLY SERVICED / REPAIRED? NO. 23. WHEN WAS THE ISSUED WITH THE PRODUCT NOTED? ON ADVANCEMENT OF THE NEEDLE. 24. WAS THE SYRINGE USED DURING THE PROCEDURE, AFTER THE STYLET WAS REMOVED? N/A. 25. WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? NO. 26. WAS IT POSSIBLE TO FULLY RETRACT THE NEEDLE INTO THE SHEATH BEFORE REMOVING THE DEVICE FROM THE PATIENT? YES 27. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? NO 28. WAS THE STYLET PARTIALLY REMOVED WHEN ADVANCING THE NEEDLE INTO THE TARGET SITE? N/A 29. HOW MANY SAMPLES WERE OBTAINED (PASSES COMPLETED) WITH THIS NEEDLE? 1 30. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? YES SEE THE FORM IF YES, PLEASE SPECIFY: 31. WAS THERE DIFFICULTY LOCKING THE SHEATH (OR NEEDLE) IN PLACE OR SLIPPING EXPERIENCED DURING USE? NO 32. WAS THERE DIFFICULTY IN ATTACHING OR DETACHING THE DEVICE TO THE ACCESSORY CHANNEL PORT ON THE SCOPE? NO 33. 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 INFORMATION 34. IF AN EBUS. PROCEDURE DID THE NEEDLE TIP HIT THE CARTILAGE RINGS OF THE TRACHEA? NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65443 | ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | C1968098 | 10827002342795 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |