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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 06/02/2014
Event Type  malfunction  
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 wire inside the handle detached.The procedure was completed with another rx cytology brush.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 wire detached.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.
 
Manufacturer Narrative
Updated based on additional information received on june 30, 2014.Investigation results: visual evaluation found the received device to be retracted and covered with dark residue.The catheter and the drive wire were bent and twisted.During functional testing, the brush extended and retracted with some difficulties due to the damage to the working length.The wire was not broken.The complaint that the wire inside the handle detached was not confirmed.The returned device showed neither evidence of the alleged issue, nor any defect which could have contributed to the event.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 batch.
 
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 wire inside the handle detached.The procedure was completed with another rx cytology brush.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 Key3901104
MDR Text Key4428562
Report Number3005099803-2014-02370
Device Sequence Number1
Product Code FDX
Combination Product (y/n)N
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 06/02/2014
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 Physician
Device Expiration Date02/19/2016
Device Model NumberM00545000
Device Catalogue Number4500
Device Lot Number16753401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/30/2014
Initial Date FDA Received06/30/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/28/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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