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

Model Number M00545000

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2013

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used during a biopsy procedure performed on (b)(6) 2013.According to the complainant, during preparation, the brush was extended out of the sheath for inspection.Then, an attempt was made to retract the brush, however, the brush got stuck and would no longer retract.The procedure was completed with another rx cytology brush.There were no patient complications as a result of this event.This event has been deemed a reportable event based on the investigation results: brush bent.

Manufacturer Narrative

(b)(4) for the investigation findings of brush bent.Investigation results: visual evaluation of the returned device found the brush bent.Functional inspection was performed and found the brush could extend without issue but would only partially retract.The complaint that the brush would not retract was confirmed.Most likely, the brush was bent during handling of the device prior to procedure.Retracting the brush would be difficult once it is bent.Therefore, the most probable root cause for the reported failure is handling damage.There is an investigation in place to address retraction issues.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.

• 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: 3656616
• MDR Text Key: 4283843
• Report Number: 3005099803-2014-01221
• 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
• Report Date: 02/10/2014

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: 08/27/2015
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 16338558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2014
• Initial Date FDA Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2013
• 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