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

Model Number M00545000

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2015

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 performed on (b)(6), 2015.According to the complainant, during preparation outside the patient, they noticed that a foreign matter was found in the bristled portion and handle cannula of the device.The procedure was not completed due to this event.The patient¿s condition was reported to be stable.

Manufacturer Narrative

Exact patient age is unknown but is over 18 years.Investigation results: a visual examination of the returned device found residue present on device and the brush was retracted.The thumb ring hypotube was bent and the catheter was twisted in two sections.A section of hypotube contained dark reddish brown residue resembling dried blood.A portion of the distal end of brush also contained dark reddish brown residue.Functionally, the brush extended and retracted without issue.The device was disassembled and more dark reddish brown residue on washer, silicon gland, and inside t-fitting was found.Although the customer states the issue of foreign matter was detected during preparation, implying the device was not used, the twisted catheter and the residue found on and inside the device are consistent with clinically used product.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 revealed that no similar complaints exist for the specified lot.

• 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: 4487951
• MDR Text Key: 16848541
• Report Number: 3005099803-2015-00176
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/09/2015

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: 03/26/2016
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 16849096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2014
• 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