ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2022-00573
- Event Type
- Malfunction
- Date Received
- August 24, 2022
- Date of Event
- December 9, 2014
- Report Date
- January 18, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K210476 DEVICE EVALUATION: THE ECHO-HD-22-C OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO CIRL. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THE FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE, "THE CLINICAL USEFULNESS OF ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION AND BIOPSY FOR RECTAL AND PERIRECTAL LESIONS" THIS FILE WAS 1 OF 4 OPENED FROM THE SOH LITERATURE PAPER; DOCUMENT REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS THE LOT NUMBER IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. THE INTENDED USE SECTION OF THE INSTRUCTIONS FOR USE, WHICH ACCOMPANIES THIS DEVICE STATES; ¿THIS DEVICE IS USED WITH AN ULTRASOUND FOR FINE NEEDLE BIOPSY, (FNB), OF SUBMUCOSAL LESIONS, MEDIASTINAL MASSES, LYMPH NODES AND INTRAPERITONEAL MASSES WITHIN OR ADJACENT TO THE GASTROINTESTINAL TRACT" THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AS THERE WAS 8 CASES OF THE DEVICE BEING USED ON RECTAL AND PERIRECTAL LESIONS. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE IT STATED INTENDED USE, IT CAN RESULT IN OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. ACCORDING TO OUR MEDICAL ADVISER, SAMPLING RECTAL AND PERIRECTAL LESIONS WAS OFF-LABEL. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, 1 PATIENT WAS DIAGNOSED WITH A PNEUMOPERITONEUM RADIOLOGICALLY AFTER EUS-FNB. HOWEVER, HE DID NOT SHOW ANY SYMPTOMS ASSOCIATED WITH PERITONITIS AND WAS DISCHARGED TWO DAYS LATER. NO ADVERSE EFFECTS FOR THE 7 OFF-LABEL CASES. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) #K210476. CANCELLATION MDR REPORT IS BEING SUBMITTED AS THIS COMPLAINT NO LONGER MEETS THE FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ REPORTING CRITERIA. AS PER REVISED CLINICAL INPUT RECEIVED, OFF LABEL USE OF DEVICE IS DEEMED NOT TO HAVE OCCURRED. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING AND NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED.
SOH ET AL 2014, THE CLINICAL USEFULNESS OF ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION AND BIOPSY FOR RECTAL AND PERIRECTAL LESIONS. EUS-FNA WAS PERFORMED USING 19- [PR 372838: SOH ET AL 2014 ¿ 6 CASES OF OFF-LABEL USAGE (ECHO-19)] OR 22-GAUGE [PR 372839: SOH ET AL 2014 ¿ 10 CASES OF OFF-LABEL USAGE (ECHO-1-22 OR ECHO-3-22)] DISPOSABLE NEEDLES (ECHOTIP ULTRA; COOK MEDICAL INC., BLOOMINGTON, IN, USA). AFTER THE FNA NEEDLE WAS ADVANCED THROUGH THE INSTRUMENT CHANNEL OF THE LINEAR-ARRAY ECHOENDOSCOPE, THE INTERNAL STYLET WAS REMOVED AND THE NEEDLE WAS RECIPROCATED BACK AND FORTH WITHIN THE LESION. THE NEEDLE WAS WITHDRAWN FROM THE SCOPE AND AIR WAS INFUSED WITH A SYRINGE TO EXTRACT THE TISSUE MATERIAL ONTO A SLIDE. AFTER CONFIRMING WHETHER THE TISSUE MATERIAL WAS ADEQUATE, THE NEEDLE WAS AGAIN PASSED THROUGH THE LESION. EUS-FNB WAS PERFORMED USING TWO DIFFERENT METHODS: TRUCUT NEEDLE BIOPSY [NON-COOK IRELAND PRODUCT] OR PROCORE NEEDLE BIOPSY. AN EUS TRUCUT USING A 19-GAUGE NEEDLE DEVICE (QUICK-CORE; COOK MEDICAL INC.) FITTED WITH A SPRING-LOADED MECHANISM WAS THE BASIC PRINCIPLE UNDERLYING THE PROCEDURE. AFTER THE NEEDLE WAS PLACED IN THE LESION, THE SPECIMEN TRAY WAS ADVANCED INTO THE LESION USING A SPRING-LOADED HANDLE TO OBTAIN CORE TISSUE. AN EUS-PROCORE NEEDLE BIOPSY WAS NEWLY INTRODUCED AS A PROCEDURE IN 2012. THUS, EUS-FNB WITH PROCORE NEEDLE WAS NOT EXAMINED IN OUR PREVIOUS REPORT AND WE NEWLY ANALYZED THE PERFORMANCE OF EUS-FNB WITH PROCORE NEEDLE IN THE PRESENT STUDY. A FINE NEEDLE BIOPSY WAS ALSO PERFORMED USING A 22-GAUGE NEEDLE DEVICE (ECHOTIP PRO-CORE-22; COOK MEDICAL INC.) WITH A REVERSE BEVEL DESIGN [PR 372840: SOH ET AL 2014 ¿ 7 CASES OF OFF-LABEL USAGE AND 1 CASE OF PAIN/ DISCOMFORT (ECHO-HD-22-C)]. THE PROCEDURE WITH A PROCORE NEEDLE BIOPSY WAS SIMILAR TO THE EUS-FNA TECHNIQUE USING RETROGRADE NEEDLE MOTION TO ACQUIRE SHEARING TISSUES; HOWEVER, THE DIFFERENCE WAS THAT THE NEEDLE FOR THE PROCORE BIOPSY WAS EQUIPPED WITH A 10-ML SUCTION SYRINGE AFTER REMOVING THE STYLET TO EXTRACT CORE TISSUES. COMPLICATIONS: TWO COMPLICATIONS OF MILD FEVER AND ASYMPTOMATIC PNEUMOPERITONEUM WERE NOTED IMMEDIATELY AFTER THE PROCEDURES. NO PATIENT EXPERIENCED ANY SEVERE COMPLICATION. -IN 1 PATIENT (NO. 11), FEVER OCCURRED 1 DAY AFTER EUS-FNA/B. ANTIBIOTICS WERE INFUSED INTRAVENOUSLY AND SHE WAS UNEVENTFULLY DISCHARGED 4 DAYS AFTER EUS-FNA/B. PROPHYLACTIC ANTIBIOTICS HAD NOT BEEN ADMINISTERED BEFORE HER EUS-FNA/B PROCEDURE. [PR 372842: SOH ET AL 2014 ¿ 1 CASE OF OFF-LABEL USAGE AND CASE OF FEVER (ECHO-19)] -ANOTHER PATIENT (NO. 14) WAS DIAGNOSED WITH A PNEUMOPERITONEUM RADIOLOGICALLY AFTER EUS-FNB. HOWEVER, HE DID NOT SHOW ANY SYMPTOMS ASSOCIATED WITH PERITONITIS AND WAS DISCHARGED TWO DAYS LATER. A TOTAL OF 22 PATIENTS (73%) RECEIVED PROPHYLACTIC ANTIBIOTICS PRIOR TO THEIR EUS PROCEDURE. [PR 372840: SOH ET AL 2014 ¿ 7 CASES OF OFF-LABEL USAGE AND 1 CASE OF PAIN/ DISCOMFORT (ECHO-HD-22-C)]. THIS FILE WILL CAPTURE THE 7 CASES OF OFF-LABEL USAGE ON RECTAL AND PERIRECTAL LESIONS AND 1 CASE OF PAIN/ DISCOMFORT USING ECHO-HD-22-C. NO ADVERSE EFFECTS FOR THE 7 OFF-LABEL CASES. PATIENT NO. 14 WAS DIAGNOSED WITH A PNEUMOPERITONEUM RADIOLOGICALLY AFTER EUS-FNB. HOWEVER, HE DID NOT SHOW ANY SYMPTOMS ASSOCIATED WITH PERITONITIS AND WAS DISCHARGED TWO DAYS LATER. THE MEDIAN AGE OF THE 30 PATIENTS WHO UNDERWENT EUS-FNA/B WAS 56 YEARS (RANGE, 33-81 YEARS), AND 18 PATIENTS WERE MALE.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON(B)(6)2023.
CANCELLATION MDR REPORT IS BEING SUBMITTED AS THIS COMPLAINT NO LONGER MEETS THE FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ REPORTING CRITERIA. AS PER REVISED CLINICAL INPUT RECEIVED, OFF LABEL USE OF DEVICE IS DEEMED NOT TO HAVE OCCURRED. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING AND NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2323739 | ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male |