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 Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: k192908.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.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.Prior to distribution, all cytomax ii double lumen cytology brushes are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.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 brush cytology in a endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook cytomax ii double lumen cytology brush.The device was used in the distal part of the bile duct.A wire guide was placed across the stenosed site, then the stenosed area was rubbed with the device.At the third attempt of rubbing, the filiform tip became separated and remained in the stenosed site.The device without the filiform tip was removed from the patient.The remained filiform tip was retrieved from the patient with forceps.A section of the device detached inside the patient¿s body.The filiform tip was retrieved from the patient with forceps.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Pma/510(k) #: k192908.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device handle and the majority of the catheter and drive wire were returned as well as the tip of the device, however the brush itself was not attached to the device.The user stated "the brush section will not be returned since it was cut off in the hospital to send it to a pathologist for tissue examination." the distal end of the catheter and drive wire showed evidence of being cut.The returned coil spring tip is approximately 17 mm long and shows signs of deformation at the proximal end.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.A lab meeting with production personnel was held to evaluate the product for manufacturing issues.No nonconformities or product-specific discrepancies were observed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: 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.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.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.

• 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
• MDR Report Key: 11361986
• MDR Text Key: 233087116
• Report Number: 1037905-2021-00073
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DLB-35-1.5-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASAHI INTECC M-THROUGH 0.025INCH WIRE GUIDE; ENDOSCOPE, UNKNOWN MAKE OR MODEL
• Patient Outcome(s): Required Intervention