MAUDE Adverse Event Report: COOK ENDOSCOPY BRONCHOSCOPE CYTOLOGY BRUSH

Catalog Number BCB-5-120-2-S

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2015

Event Type  malfunction  

Event Description

During a bronchoscopy procedure, the physician used a cook bronchoscope cytology brush.The brush was extended & pulled back into the sheath, then "disappeared." the user looked in the lungs and then an x-ray was performed.The brush could not be seen in the lungs.The brush was removed from the endoscope & found broken at the distal end but remained in the outer sheath.The device was sent to the lab for histology.The patient was reintubated to complete the bronchoscopy.A section of the device did not remain inside the patient's body.Other than the patient reintubated to complete the bronchoscopy, the patient did require any additional procedures dud to this occurrence, according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed w/the product that was released for distribution.Investigation conclusions: 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 bronchoscope cytology brushes are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that this lot met manufacturing requirements prior to shipment.A review of the complaint history was conducted & 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.Qa will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

Manufacturer Narrative

Initially, the following information was provided to cook: during a bronchoscopy procedure, the physician used a cook bronchoscope cytology brush.The brush was extended and pulled back into the sheath, then "disappeared." the user looked in the lungs and then an x-ray was performed.The brush could not be seen in the lungs.The brush was removed from the endoscope and found broken but remained in the outer sheath.The device sent to the lab for histology.The patient was reintubated to complete the bronchoscopy.An initial mdr was submitted on (b)(4) 2015 based on this information.On (b)(4) 2015 cook received the adverse incident report from surgical materials testing laboratory (smtl) for the used device.The report states: handle came detached from sheath during procedure.On (b)(4) 2015 one (1) opened unused device and (b)(4) sealed devices were returned to cook for evaluation.The shrink tubing on the opened unused device is located approximately 2.8 cm from the handle.The opened unused device as stated from the cook representative was to display what was wrong with the used device that was sent to smtl.Since the actual device used in the procedure was sent to smtl for evaluation and their report states the handle came detached from sheath during procedure; it is reasonable to suggest the actual description of event was that the handle became detached from the sheath which resulted in the appearance that the distal end was broken and remained in the outer sheath [unable to advance from sheath].

Event Description

This correction follow up report is being submitted to cancel the initial report submitted relating to this event.

Manufacturer Narrative

On 9/8/2015, we became aware that the information provided in the other remarks section was not submitted on the follow up #1 emdr.Investigation evaluation: one (1) product was returned in an open pouch from the lot number provided in the report.Ten (10) sealed devices from the lot number said to be involved were also included in the return.The report could not be confirmed, the product used in this report was not returned for evaluation.The shrink tubing on the opened device is located approximately 2.8 cm from handle.To demonstrate workability of the handle, the device was coiled into two (2) loops.There was no unexpected resistance while working the handle and the brush fully extended/retracted each time.The extension of the brush from the catheter is approximately 2.4 cm.A manual tug inspection was conducted to ensure the brush tip was secure.There is a relatively large kink at approximately 113.5 cm from the distal end.There are several other minor kinks throughout the length of the catheter.The sealed devices underwent the same functionality testing by coiling the device into two (2) loops and working the handle.There was no unexpected resistance while working the handle and the brush fully extended/retracted each time.Manual tug inspections were conducted to ensure the brush tips were secure.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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 conclusions: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.Prior to distribution, all bronchoscope cytology brushes are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that this lot met manufacturing requirements prior to shipment.Corrective action: see initial report.

• Brand Name: BRONCHOSCOPE CYTOLOGY BRUSH
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr., reg. comm. ; 4900 bethania station rd. &; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4945730
• MDR Text Key: 21540336
• Report Number: 1037905-2015-00314
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K896318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor,company represent
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2018
• Device Catalogue Number: BCB-5-120-2-S
• Device Lot Number: W3566240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2015
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/01/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2015
• 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