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

Model Number M00545000

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure was performed on (b)(6) 2015.According to the complainant, during the procedure, the brush was extremely difficult to pass through the scope.Excessive force is required to get brush through scope and into the bile duct.Brush only advanced once through the stricture and back into cannula.Brush would not advance through stricture when handle was pushed forward.When the device was removed from the scope, it was noted that the wire in the handle broke and the catheter kinked.The brush was cut off and sent to cytology.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be "ok".

Manufacturer Narrative

Visual evaluation of the returned device revealed that the catheter working length was bent and twisted in multiple places throughout.The pull wire had been cut and was extended beyond the distal end of the sheath.The brush bristle section was missing and was not returned.The thumb ring would extend and retract without resistance, but the pull wire did not move.Assessment found that the pull wire had broken at the end of the hypotube.The bends and twists in the device and the difficulty in engaging the target vessel were most likely due to some aspects of tortuous anatomy or other operational factors of the procedure.Therefore, the most probable root cause classification is "operational context".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.A search of the complaint database confirmed that no other complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure was performed on (b)(6) 2015.According to the complainant, during the procedure, the brush was extremely difficult to pass through the scope.Excessive force is required to get brush through scope and into the bile duct.Brush only advanced once through the stricture and back into cannula.Brush would not advance through stricture when handle was pushed forward.When the device was removed from the scope, it was noted that the wire in the handle broke and the catheter kinked.The brush was cut off and sent to cytology.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be ¿ok¿.

• 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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5283279
• MDR Text Key: 33107491
• Report Number: 3005099803-2015-03489
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 18251236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2015
• 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