ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
Report
- Report Number
- 3001845648-2023-00786
- Event Type
- Malfunction
- Date Received
- October 20, 2023
- Date of Event
- September 22, 2023
- Report Date
- July 30, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 10827002520124
- PMA / PMN Number
- K092359
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) # K092359. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION: THE ECHO-HD-19-A DEVICE OF LOT NUMBER C1994186 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, OPEN WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 18 OCTOBER 2023 AND LAB RE-EVALUATION ON 20 JUNE 2024. THE RETURNED DEVICE LAB FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH THE ATTACHED FILES. ON EVALUATION OF THE DEVICE THE FOLLOWING OBSERVATIONS WERE MADE: VISUAL INSPECTION: STYLET RETURNED REMOVED FROM THE DEVICE, STYLET EXAMINED AND NO ISSUE OBSERVED, DISTAL END OF NEEDLE OBSERVED TO BE BROKEN APPROX 0.2 CM FROM TIP OF SHEATH, ATTEMPTED TO REINSERT STYLET BUT DOES NOT PASS KINK BELOW SHEATH EXTENDER, NEEDLE REMOVED FROM DEVICE AND KINK OBSERVED BELOW SHEATH EXTENDER, NEEDLE REMOVED FROM THE DEVICE AND PROXIMAL NEEDLE BREAK OBSERVED BELOW SHEATH EXTENDER. FUNCTIONAL INSPECTION: SHEATH EXTENDER ABLE TO ADVANCE AND RETRACT WITH NO ISSUE, NEEDLE HANDLE UNABLE TO ADVANCE OR RETRACT, PROXIMAL KINK OBSERVED BELOW SHEATH EXTENDER. CLARIFICATION WAS RECEIVED FROM THE CUSTOMER AS BELOW. 1. THE DISTAL END OF NEEDLE WAS OBSERVED TO BE BROKEN AFTER THE PROCEDURE PRIOR TO THE DEVICE GETTING SHIPPED BACK TO CIRL? NO. 2. THE PROXIMAL KINK BELOW THE SHEATH EXTENDER WAS OBSERVED AFTER THE PROCEDURE PRIOR TO THE DEVICE GETTING SHIPPED BACK TO CIRL? NO. 3. THE PROXIMAL NEEDLE BREAK WAS OBSERVED AFTER THE PROCEDURE PRIOR TO THE DEVICE GETTING SHIPPED BACK TO CIRL? NO NEEDLE BREAK OR SHEATH EXTENDER KINK WAS OBSERVED BEFORE DEVICE RETURN BACK. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT LAB RE-EVALUATION AND THE FOLLOWING OBSERVATIONS WERE MADE: VISUAL INSPECTION: NO ISSUE WITH STYLET OBSERVED, NO ISSUE WITH DISTAL END OF NEEDLE OBSERVED, IT SHOULD BE NOTED THAT THE PROXIMAL KINK AND BREAK BELOW SHEATH EXTENDER ARE BOTH LOCATED AT THE SAME POSITION ON THE DEVICE. ITS MOST LIKELY THAT THE PROXIMAL BREAK OBSERVED DURING LAB EVALUATION WOULD HAVE OCCURRED DUE TO THE SEVERE KINK. CUSTOMER CONFIRMED THAT THEY DID NOT OBSERVE THE PROXIMAL KINK OR BREAK THEREFORE THESE COULD HAVE OCCURRED DURING DEVICE HANDLING AFTER THE PROCEDURE OR DEVICE RETURNS PROCESS AS THE DEVICE WAS NOT RETURNED IN ITS ORIGINAL PACKAGING. IF ANY FURTHER INFORMATION WILL BE PROVIDED IN THE FUTURE, THE FILE WILL BE RE-OPENED AND UPDATED ACCORDINGLY. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-HD-19-A DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-19-A OF LOT NUMBER C1994186 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 WITH THE LOT NUMBER C1994186. INSTRUCTIONS FOR USE AND/LABEL: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, (IFU0050) 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 " AND ¿IDENTIFY DESIRED BIOPSY/INJECTION SITE BY ENDOSCOPIC ULTRASOUND". THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. THERE MAY BE SEVERAL POSSIBLE CAUSES FOR THE ADVANCEMENT/RETRACTION OF THE NEEDLE ISSUE REPORTED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO POSITIONING OF THE DEVICE WITHIN THE SCOPE, THE DEVICE POSSIBLY BEING HELD AT AN ANGLE AND THE ENDOSCOPE BEING IN A FLEXED OR TWISTED POSITION DURING THE PROCEDURE AS INDICATED IN THE ADDITIONAL INFORMATION PROVIDED ¿21. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? YES¿. THEREFORE, IT IS POSSIBLE THAT THIS MIGHT HAVE CONTRIBUTED TO THE DIFFICULTY IN ADVANCEMENT AND RETRACTION OF THE NEEDLE. IN ADDITION, POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO ADVANCEMENT INTO A HARD LESION OR THROUGH HARD TISSUE DURING THE PUNCTURE ATTEMPT WHICH COULD HAVE RESULTED IN ADVANCEMENT DIFFICULTIES ENCOUNTERED. ALTHOUGH IT WAS ADVISED TARGET SITE WAS NOT DIFFICULT, IT IS POSSIBLE THAT THE NEEDLE TIP OF THE DEVICE CAME INTO CONTACT WITH A HARD LESION DURING THE FIRST SUCCESSFUL PASS LEADING TO THE DISTAL END OF THE NEEDLE GETTING STUCK AT SOME POINT DURING THE PROCEDURE AND SUBSEQUENTLY LEADING TO THE RETRACTION DIFFICULTIES. 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.
USER DETECTED THE NEEDLE CANNOT BE PULLED OUT AND INSERTED BACK. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE."
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 30-JUL-2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1962344 | ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | C1994186 | 10827002520124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male |