MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY 3MM STERILE DISP CYTOL 20/CS; ENDOSCOPIC CYTOLOGY BRUSH

Catalog Number 149R

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2021

Event Type  malfunction  

Manufacturer Narrative

At time of filing, the reported device is not expected to be returned to conmed for evaluation.This reported event is entering the investigation process.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, the distributor reported issues with the 149r - 3mm sterile disposable cytology brush, lot 202107194, that therapak llc recently experienced on (b)(6) 2021.Information received indicates while performing a bronchoscopy a piece of sheathing broke off and became lodged inside the patient airway.Upon further inspection it appeared as if the sheath had been double cut just above the length of the brush, if the brush was in the out position.When pressure was applied the lower segment of the sheath became loose and ultimately lodged inside the patient airway.Forceps had to be used to retrieve the fragment.The length of the sheathing was the length of the brush.Time to removal was 1 min.It was noted there was no impact or injury to the (b)(6) female patient, and the procedure was successfully completed with 1 minute delay using an alternate.Another conmed disposable bronchial cytology brush (149r), lot 202107194, was inspected for damage, and used to complete the procedure.The patient was released without incident or harm.A note was added in the patient case record.The brush and fragment were disposed of at the site.Additional information received notes approximately 1 minute into the procedure, when the brush was deployed, the physician saw the plastic piece dislodge and immediately took steps to remove the piece.There was nothing unusual or of special concern noted regarding the patient¿s anatomy.There was no resistance in placing / inserting the device.A bronchoscope was also being used during the procedure.Therapak procures and distributes the brushes for veracyte, inc.The brushes are used for the collection of specimens for veracyte¿s clinical test.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence, as although the piece was removed, it did fall into the patient.

Manufacturer Narrative

Investigation of the customer's complaint is inconclusive.The reported device has not been returned to conmed for evaluation & no photographic evidence was provided.Therefore, reported failure cannot be verified, & root cause cannot be identified.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A two-year lot history review was conducted and found this is the only event reported for this lot number and failure mode.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Also, per the ifu, the user is advised that when the bronchoscope is in desired position, advance the catheter with brush inside to area for cytological sample.Push the brush handle to advance the brush 5 cm past the distal end of the catheter.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, the distributor reported issues with the 149r - 3mm sterile disposable cytology brush, lot 202107194, that therapak llc recently experienced on (b)(6) 2021.Information received indicates while performing a bronchoscopy a piece of sheathing broke off and became lodged inside the patient airway.Upon further inspection it appeared as if the sheath had been double cut just above the length of the brush, if the brush was in the out position.When pressure was applied the lower segment of the sheath became loose and ultimately lodged inside the patient airway.Forceps had to be used to retrieve the fragment.The length of the sheathing was the length of the brush.Time to removal was 1 min.It was noted there was no impact or injury to the 75yr old female patient, and the procedure was successfully completed with 1minute delay using an alternate.Another conmed disposable bronchial cytology brush (149r), lot 202107194, was inspected for damage, and used to complete the procedure.The patient was released without incident or harm.A note was added in the patient case record.The brush and fragment were disposed of at the site.Additional information received notes approximately 1 minute into the procedure, when the brush was deployed, the physician saw the plastic piece dislodge and immediately took steps to remove the piece.There was nothing unusual or of special concern noted regarding the patient¿s anatomy.There was no resistance in placing / inserting the device.A bronchoscope was also being used during the procedure.Therapak procures and distributes the brushes for veracyte, inc.The brushes are used for the collection of specimens for veracyte¿s clinical test.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence, as although the piece was removed, it did fall into the patient.

• Brand Name: 3MM STERILE DISP CYTOL 20/CS
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: tracey weiselbenton ; conmed corporation; 11311 concept blvd; largo, FL 33773 ; 7273995557
• MDR Report Key: 13002367
• MDR Text Key: 284030973
• Report Number: 3007305485-2021-00432
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 149R
• Device Lot Number: 202107194
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic