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

Model Number M00545000

Device Problems Mechanical Problem (1384); Retraction Problem (1536); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

The exact age of the patient is unknown.However, it was reported the patient was over 18 years.(b)(4).The device has been received for analysis.Upon 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.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was opened for use in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during preparation and outside the patient, when functional check was performed, the brush was difficult to extend and retract.It was also noted that the bristled portion of the brush was bent.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was opened for use in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during preparation and outside the patient, when functional check was performed, the brush was difficult to extend and retract.It was also noted that the bristled portion of the brush was bent.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.

Manufacturer Narrative

The exact age of the patient is unknown.However, it was reported the patient was over 18 years.(b)(4).Visual evaluation of the returned device revealed that no visual defects were noted and the brush was not bent.Functional evaluation of the device revealed that the brush was able to extend and retract without any issues.Dimensional inspection was performed and the brush extension measured at 3.8 cm while the brush retraction measured at 1.5 cm, within manufacturing specification.Based on the information available and the analysis performed, the most probable root cause is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: RX CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8175273
• MDR Text Key: 130916463
• Report Number: 3005099803-2018-62075
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• 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
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

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: 06/26/2020
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0022309929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1