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

Model Number M00545000

Device Problems Detachment Of Device Component (1104); Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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

Note: this report pertains to one of two complaint devices used in the same procedure.Manufacturer report # 3005099803-2016-03586 and 3005099803-2016-03587 address both rx cytology brush.It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during an exfoliative cytodiagnosis procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the physician encountered resistance when brush was advanced through the stricture.The distal tip of the brush was detached and was left inside the bile duct.An endoscopic sphincterotomy (est) was performed and expected that the distal tip would pass naturally.The procedure was completed with this device.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 good.

Manufacturer Narrative

Investigation results: detailed analysis of the returned rx cytology brush revealed that the device bent and twisted at the distal end.The tip was found damaged and the pullwire was broken.The bristle portion of the brush was not returned and the cannula was in good condition.Functional evaluation found that the guidewire was loaded in the device and there was no resistance encountered.The brush could be extended and retracted without issue.The damage to the returned device was most likely due to tortuous anatomical and/or other operational factors encountered during the procedure.Therefore, the most probable root cause classification is "operational context.".

Event Description

Note: this report pertains to one of two complaint devices used in the same procedure.Manufacturer report # 3005099803-2016-03586 and 3005099803-2016-03587 address both rx cytology brush.It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during an exfoliative cytodiagnosis procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the physician encountered resistance when brush was advanced through the stricture.The distal tip of the brush was detached and was left inside the bile duct.An endoscopic sphincterotomy (est) was performed and expected that the distal tip would pass naturally.The procedure was completed with this device.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 good.

• 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: 6115421
• MDR Text Key: 60436359
• Report Number: 3005099803-2016-03586
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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