CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
Report
- Report Number
- 1037905-2024-00306
- Event Type
- Injury
- Date Received
- May 31, 2024
- Date of Event
- May 7, 2024
- Report Date
- May 31, 2024
- Manufacturer
- WILSON-COOK MEDICAL INC
- Product Code
- FDX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
SECTION G: PMA/510(K): K192908 INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A CLEAR PLASTIC BIOHAZARD BAG. PROVIDED WITH THE RETURN WAS AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. PICTURES WERE PROVIDED AND REVIEWED. TWO PICTURES SHOW THE LABEL ON THE POUCHES OF THE POSSIBLE LOT NUMBERS ASSOCIATED WITH THE RELATED COMPLAINT (COOK REFERENCE (B)(4). THE THIRD PICTURE IS A X-RAY IMAGE WHICH SHOWED THE DEVICE DURING USE WITH THE TIP DETACHED INSIDE THE PATIENT. THE FOURTH PICTURE SHOWS THE TIP AFTER IT WAS RETRIEVED. THE SAME PICTURES ARE ATTACHED TO THE RELATED COMPLAINT (COOK REFERENCE (B)(4). OUR EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE COMPLAINT. THE DEVICE WAS RETURNED WITH ONLY THE CATHETER AND THE DETACHED COIL SPRING. THE DRIVE WIRE TO HANDLE CANNULA ASSEMBLY WITH BRUSH WAS NOT INCLUDED IN THE RETURN. THE RETURNED COIL SPRING TIP MEASURED APPROXIMATELY 17 MM LONG AND PRESENTED WITH A BEND. DUE TO THE CONDITION OF THE RETURNED DEVICE A FULL EVALUATION WAS NOT POSSIBLE AND WE WERE UNABLE TO DETERMINE A CAUSE FOR THE COIL SPRING DETACHING FROM THE BRUSH. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OCCURRENCE WAS NOT OBSERVED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. HOWEVER, A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE CONDITION OF THE PRODUCT SAID TO BE INVOLVED PROHIBITED A COMPLETE EVALUATION. WITHOUT THE BRUSH AT THE DISTAL END OF THE DEVICE, THE JOINT BETWEEN THE BRUSH AND THE COIL SPRING TIP COULD NOT BE FULLY EVALUATED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. PRIOR TO DISTRIBUTION, ALL CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSHES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED A COOK CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH. IT WAS REPORTED [THAT THE] BRUSH BROKE INSIDE OF A PATIENT. HE [PHYSICIAN] WAS ABLE TO RETRIEVE IT. IMAGES PROVIDED OF DETACHED CYTOLOGY BRUSH PORTION. THE DETACHED DEVICE PORTION DID NOT REMAIN INSIDE THE PATIENT. AN ADDITIONAL PROCEDURE WAS REQUIRED TO RETRIEVED DETACHED DEVICE POTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1400566 | CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH | FDX ENDOSCOPIC CYTOLOGY BRUSH | FDX | WILSON-COOK MEDICAL INC | W4808420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | ENDOSCOPE, UNKNOWN MAKE AND MODEL |