MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER RX CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH

Model Number M00545000

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the bile duct during a cytology procedure performed on (b)(6), 2014.According to the complainant, during the procedure, the brush was moved in and out, and eventually removed while the guide wire was still positioned.The distal tip of the sheath of the brush was found to be torn.Another rx cytology brush was then advanced through the endoscope, and the brush was pushed out.Fluoroscopy was performed and showed that the radiopaque marker from the first brush had detached, and remained in the upper bile duct.The procedure was completed with a different device.Reportedly, a functional check was performed done prior to use, and the anatomy was not tortuous.The physician intends to retrieve the detached radiopaque marker at a later date, since he does not believe it will pass naturally.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4): the device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

A visual evaluation of the returned device found the working length bent and kinked throughout.The catheter was noted to be torn from the distal end of the guide wire exit port down to the distal tip of the catheter.The radiopaque marker was not returned.The complaint that the radiopaque marker detached and the catheter tore was confirmed.Based on the product analysis, most likely the customer did not follow the guidance in device removal section of the directions for use, which instructs the user to perform a standard device exchange.In this case it appears the user performed a tear-away exchange; therefore, the most probable root cause for the reported complaint is user/use error.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the bile duct during a cytology procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the brush was moved in and out, and eventually removed while the guide wire was still positioned.The distal tip of the sheath of the brush was found to be torn.Another rx cytology brush was then advanced through the endoscope, and the brush was pushed out.Fluoroscopy was performed and showed that the radiopaque marker from the first brush had detached, and remained in the upper bile duct.The procedure was completed with a different device.Reportedly, a functional check was performed done prior to use, and the anatomy was not tortuous.The physician intends to retrieve the detached radiopaque marker at a later date, since he does not believe it will pass naturally.There were no patient complications reported as a result of this event.

• Brand Name: RX CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3790571
• MDR Text Key: 4370576
• Report Number: 3005099803-2014-01897
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2016
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 16672959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2014
• Initial Date FDA Received: 05/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR