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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER RX CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH
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BOSTON SCIENTIFIC - SPENCER RX CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH Back to Search Results
Model Number M00545000
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/08/2014
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure with histological diagnosis performed on (b)(6) 2014.According to the complainant, during the procedure, the sheath bent then detached before the tip of the brush exit at the distal end of the sheath, thus, making the physician unable to use the brush in performing cytology.The procedure was completed with different 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
Reported event of working length detached.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 medwatch will be filed.
 
Manufacturer Narrative
Investigation results: a visual evaluation of the returned device found that the catheter and the drive wire were severely kinked throughout.Also, the handle was bent approximately 2.7 cm from the orange thumb ring.The blue cap was received completely loosened and pulled out of the t-fitting.The catheter was not detached.Functional inspection was performed, and the drive wire did not move when the handle was actuated.The handle assembly was then disassembled, and it was found that the drive wire had broken near where it joins with the hypotube.The complaint that the working length detached was not confirmed; however, the investigation confirmed the complaint of working length bent.Most likely, the working length kinked during insertion of the brush into the endoscope.Continued efforts to extend the brush against these kinks would cause the handle to bend and would eventually break the pull wire.Therefore, the most probable root cause of the identified failures 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 revealed 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 during an endoscopic retrograde cholangiopancreatography (ercp) procedure with histological diagnosis performed on (b)(6) 2014.According to the complainant, during the procedure, the sheath bent then detached before the tip of the brush exit at the distal end of the sheath, thus, making the physician unable to use the brush in performing cytology.The procedure was completed with different 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.
 
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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 Key3790196
MDR Text Key4437493
Report Number3005099803-2014-01887
Device Sequence Number1
Product Code FDX
Combination Product (y/n)N
Reporter Country CodeKR
PMA/PMN Number
K930348
Number of Events Reported1
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 04/08/2014
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 Date02/28/2016
Device Model NumberM00545000
Device Catalogue Number4500
Device Lot Number16779900
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/02/2014
Initial Date FDA Received05/05/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/26/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age47 YR
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