UNKNOWN
Report
- Report Number
- 3001845648-2024-00171
- Event Type
- Injury
- Date Received
- April 11, 2024
- Date of Event
- July 17, 2014
- Report Date
- November 4, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS ONGOING A FOLLOW UP MDR WILL BE PROVIDED PENDING RESULTS AND CONCUSSIONS OF THE INVESTIGATION.
PMA/510(K)#: K210476. SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE DEVICE RETURNED AND LAB EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 12-JUL-2024: ¿[CONFIRMATION INSUFFICIENT INFORMATION TO ATTRIBUTE COOK DEVICE AS CAUSE OF PATIENT DEATH] (ON (B)(6), (B)(4) _CIRL_ CLINICAL ADVISOR RESPONSE_AG_ON (B)(6) 2024.MSG)¿. CLINICAL ADVISOR CONFIRMED THAT THERE WAS INSUFFICIENT INFORMATION THAT THE COOK DEVICE CAUSED PATIENT DEATH AND DOES NOT IMPACT ON THE AE ASSESSMENT. BASED ON THIS INFORMATION A RE-ASSESSMENT IS NOT REQUIRED. THIS INFORMATION WILL NOT IMPACT THE REPORTABILITY DECISION OF THE FILE. FEMA SECTION WILL BE VERIFIED AT END OF INVESTIGATION. AGREEMENT FROM CI THAT THIS FILE CAN BE CANCELLED 04-NOV-2024. ARTICLE DOES NOT GIVE CONFIRMATION ON DEFINITIVE NUMBERS FOR THE PATIENTS THAT EXPERIENCED ¿PAIN, PANCREATITIS, BLEEDING, FEVER, AND INFECTION OR FOR TUMOR SEEDING AND PERFORATION THERE IS ALSO NO CONFIRMATION THAT THEY WERE RELATED TO THE COOK NEEDLES. INSUFFICIENT INFORMATION IN THE ARTICLE THAT THE AES RELATED TO A CIRL DEVICE.
PLEASE NOTE, IT CANNOT BE CONFIRMED THAT ANY OF THE ABOVE LISTED AE'S OCCURRED WITH A COOK DEVICE AS DEVICES FROM VARIOUS MANUFACTURERS DEVICES WERE POTENTIALLY USED (COOK MEDICAL, BOSTON SCIENTIFIC, CONMED CORPORATION, COVIDIEN GI SOLUTIONS AND OLYMPUS) THEREFORE THIS COMPLAINT IS BEING REPORTED CONSERVATIVELY BASED ON THE POTENTIAL FOR INJURY IF THESE AE'S OCCURRED WITH THE USE OF A COOK DEVICE AND THAT THERE MAY HAVE BEEN INTERVENTION TO TREAT. WANI, 2014¿ EUS-GUIDED TISSUE ACQUISITION: AN EVIDENCE-BASED APPROACH ADVERSE EVENTS ASSOCIATED WITH EUS-TA: THE PERFORMANCE OF EUS-FNA IS GENERALLY SAFE, AND ADVERSE EVENTS ARE RARE. IN A SYSTEMATIC REVIEW OF 51 STUDIES INVOLVING 10,941 PATIENTS, ADVERSE EVENTS WERE REPORTED IN 0.98%.251 PANCREATITIS HAS BEEN REPORTED IN UP TO 2% OF FNAS OF PANCREATIC LESIONS, WITH A RATE OF 0.44% IN THE AFOREMENTIONED SYSTEMATIC REVIEW.252-254 GIVEN THIS LOW RATE OF OCCURRENCE, NO SPECIFIC FACTORS SUCH AS NEEDLE SIZE, NEEDLE TYPE, LESION TYPE, OR LESION LOCATION HAVE BEEN IDENTIFIED. EXTRALUMINAL BLEEDING HAS BEEN REPORTED IN 1.3% OF CASES IN ONE STUDY OF 227 PATIENTS UNDERGOING EUS-FNA, ALL OF WHICH WERE CONTROLLED VIA TAMPONADE WITH THE ECHOENDOSCOPE. 255 SELF-LIMITED INTRACYSTIC BLEEDING, WITH RATES AS HIGH AS 6%, AND HEMOSUCCUS PANCREATICUS HAVE BEEN REPORTED FROM EUS-FNA OF PANCREATIC CYSTIC LESIONS. 256-258 THE USE OF LOW MOLECULAR WEIGHT HEPARIN, BUT NOT ASPIRIN OR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS, WAS ASSOCIATED WITH AN INCREASED RATE OF BLEEDING EVENTS IN 222 PROCEDURES WITH EUS-FNA OR TRU-CUT BIOPSY.259 BACTEREMIA RESULTING FROM EUS-FNA IS EXTREMELY UNCOMMON AND COMPARABLE TO EUS WITHOUT FNA. PROSPECTIVE STUDIES HAVE FOUND THIS TO BE TRUE FOR BOTH EUS-FNA OF LESIONS IN THE UPPER AND LOWER GI TRACT.260-263 AS A RESULT OF THESE DATA, ROUTINE ANTIBIOTIC USE IS NOT RECOMMENDED FOR EUS-FNA OF SOLID LESIONS WITHIN OR ADJACENT TO THE UPPER OR LOWER GI TRACT. CYSTIC LESIONS ARE AT HIGHER RISK OF INFECTION. ASPIRATION OF MEDIASTINAL CYSTS HAS BEEN ASSOCIATED WITH INFECTION AND MEDIASTINITIS AND, GIVEN THE LIMITED ADVERSE EVENTS ASSOCIATED WITH EUS-TA: THE PERFORMANCE OF EUS-FNA IS GENERALLY SAFE, AND ADVERSE EVENTS ARE RARE. IN A SYSTEMATIC REVIEW OF 51 STUDIES INVOLVING 10,941 PATIENTS, ADVERSE EVENTS WERE REPORTED IN 0.98%.251 TWO DEATHS ATTRIBUTABLE TO PERFORMING EUSFNA WERE IDENTIFIED, ONE FROM CHOLANGITIS AND ONE FROM PANCREATITIS, FOR A MORTALITY RATE OF 0.02%. HIGHER RATES OF ADVERSE EVENTS WERE IDENTIFIED IN PROSPECTIVE STUDIES COMPARED WITH RETROSPECTIVE STUDIES (1.72% VS 0.64%; P! .001). EUS-FNA PROCEDURES TARGETING ASCITES AND PANCREATIC CYSTS WERE ASSOCIATED WITH THE HIGHEST RATES OF ADVERSE EVENTS. PAIN, PANCREATITIS, BLEEDING, FEVER, AND INFECTION WERE THE MOST FREQUENTLY REPORTED ADVERSE EVENTS. TUMOR SEEDING AND PERFORATION ARE ADDITIONAL SERIOUS, BUT INFREQUENTLY REPORTED, ADVERSE EVENTS FROM EUS-FNA. PANCREATITIS HAS BEEN REPORTED IN UP TO 2% OF FNAS OF PANCREATIC LESIONS, WITH A RATE OF 0.44% IN THE AFOREMENTIONED SYSTEMATIC REVIEW.252-254 GIVEN THIS LOW RATE OF OCCURRENCE, NO SPECIFIC FACTORS SUCH AS NEEDLE SIZE, NEEDLE TYPE, LESION TYPE, OR LESION LOCATION HAVE BEEN IDENTIFIED. EXTRALUMINAL BLEEDING HAS BEEN REPORTED IN 1.3% OF CASES IN ONE STUDY OF 227 PATIENTS UNDERGOING EUS-FNA, ALL OF WHICH WERE CONTROLLED VIA TAMPONADE WITH THE ECHOENDOSCOPE. 255 SELF-LIMITED INTRACYSTIC BLEEDING, WITH RATES AS HIGH AS 6%, AND HEMOSUCCUS PANCREATICUS HAVE BEEN REPORTED FROM EUS-FNA OF PANCREATIC CYSTIC LESIONS.256-258 THE USE OF LOW MOLECULAR WEIGHT HEPARIN, BUT NOT ASPIRIN OR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS, WAS ASSOCIATED WITH AN INCREASED RATE OF BLEEDING EVENTS IN 222 PROCEDURES WITH EUS-FNA OR TRU-CUT BIOPSY.259 BACTEREMIA RESULTING FROM EUS-FNA IS EXTREMELY UNCOMMON AND COMPARABLE TO EUS WITHOUT FNA. PROSPECTIVE STUDIES HAVE FOUND THIS TO BE TRUE FOR BOTH EUS-FNA OF LESIONS IN THE UPPER AND LOWER GI TRACT.260-263 AS A RESULT OF THESE DATA, ROUTINE ANTIBIOTIC USE IS NOT RECOMMENDED FOR EUS-FNA OF SOLID LESIONS WITHIN OR ADJACENT TO THE UPPER OR LOWER GI TRACT. CYSTIC LESIONS ARE AT HIGHER RISK OF INFECTION. ASPIRATION OF MEDIASTINAL CYSTS HAS BEEN ASSOCIATED WITH INFECTION AND MEDIASTINITIS AND, GIVEN THE LIMITED CYTOLOGIC YIELD OF ASPIRATING SUCH LESIONS, FNA OF THESE LESIONS IS GENERALLY NOT RECOMMENDED.218 THE DATA REGARDING THE USE OF PROPHYLACTIC ANTIBIOTICS IN PANCREATIC CYSTS UNDERGOING EUS-FNA ARE EQUIVOCAL. ALTHOUGH A CYST INFECTION RATE OF 14% WAS REPORTED IN AN INITIAL SERIES OF 22 PATIENTS UNDERGOING CYST FNA,264 A RECENT RETROSPECTIVE COHORT STUDY OF ANTIBIOTIC PROPHYLAXIS FOR EUS-FNA OF PANCREATIC CYSTS IDENTIFIED ONE POSSIBLE INFECTION EACH IN 88 PATIENTS TREATED WITH ANTIBIOTICS AND 178 PATIENTS GIVEN NO ANTIBIOTICS. 265 TUMOR SEEDING HAS BEEN REPORTED AFTER ASPIRATION OF PANCREATIC ADENOCARCINOMA, INTRADUCTAL PAPILLARY MUCINOUS NEOPLASM, MELANOMA, AND MALIGNANT ADENOPATHY. CAUTION IN PERFORMING BILE DUCT EUS-FNA FOR PRIMARY TUMOR DIAGNOSIS (CHOLANGIOCARCINOMA) HAS BEEN RECOMMENDED BECAUSE OF THE POTENTIAL RISK OF TUMOR SEEDING ASSOCIATED WITH TRANSPERITONEAL TISSUE ACQUISITION, ALTHOUGH 13 OF 16 PATIENTS IN THIS STUDY UNDERWENT PERCUTANEOUS PROCEDURES.274 PERFORATIONS REPORTED WITH EUS-FNA HAVE BEEN ATTRIBUTED TO PASSAGE OF THE ECHOENDOSCOPE RATHER THAN THE NEEDLE.275 THE RATES OF ADVERSE EVENTS ASSOCIATED WITH NEEDLES DESIGNED TO OBTAIN HISTOLOGY VIA EUS-FNB HAVE BEEN COMPARABLE TO THOSE REPORTED FOR EUS-FNA.88,90,91,118,119,121,130,276-278 FINALLY, FALSE-POSITIVE DIAGNOSES ASSOCIATED WITH EUS-TA MAY OCCUR, WITH REPORTED INCIDENCES RANGING FROM 1.1% TO 5.3%.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE DEVICE RETURNED AND LAB EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1333105 | UNKNOWN | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |