MAUDE Adverse Event Report: COOK ENDOSCOPY CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH; FDX ENDOSCOPIC CYTOLOGY BRUSH

Catalog Number DLB-35-1.5-S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

510(k): k192908.Investigation evaluation: a product evaluation was performed only by the pictures provided with this report because the product said to be involved was not provided to cook for evaluation.A photo of the lot number was not provided.The report was confirmed with the photos provided.The first photo shows the brush extended from the tip of the catheter with the coil spring attached.The second photo shows the brush extended from the tip of the catheter.The coilspring and a portion of the brush appear to be missing.The catheter is bending slightly at the end distal end.An additional photo provided by the user shows the device coiled inside the packaging with fluid inside the catheter and the brush tip missing, as well as a portion of the brush.A slightly bent portion of the brush wire without bristles on it can be seen.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the photos provided and statements describing the event.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use including the following: "after obtaining specimen, retract brush into sheath." failure to retract the brush into the sheath may cause excess force on the device during removal from the scope.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.

Event Description

During a cytology procedure, the physician used a cook cytomax ii double lumen cytology brush.The brush was used to brush a common bile duct (cbd) stricture, and upon removal of the cytology brush, the 1.5 cm filiform tip broke off and was left as foreign body in the cbd.It was not able to be removed.The retrieval of the tip was attempted, but failed.A section of the device remained in the patient's body.Removal was attempted but failed.According to the reporter, no further procedure is planned to remove it.

• Brand Name: CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
• Type of Device: FDX ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 12467761
• MDR Text Key: 271292526
• Report Number: 1037905-2021-00491
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 10827002226743
• UDI-Public: (01)10827002226743(17)230914(10)W4384791
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2023
• Device Catalogue Number: DLB-35-1.5-S
• Device Lot Number: W4384791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, UNKNOWN MAKE OR MODEL
• Patient Outcome(s): Required Intervention