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 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported to boston scientific corporation that a rx cytology brush was used in an unknown procedure performed on (b)(6) 2018.According to the complainant, during preparation, the brush failed to retract, and the bristled portion of the brush was noted to be bent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

A visual evaluation of the returned rx cytology brush revealed that the device was received in extended position.The working length (extrusion and pull wire) was free from obvious kinks and bends.No visual issues were noted on the device.Functional analysis was performed and showed that the brush extends properly however; it was unable to retract completely.Further evaluation noted that the brush tip remained outside the catheter when handle was in closed/retracted position.The device was inspected and its measurements were found to be within manufacturing specification.Based on all gathered information, the most probable cause of this complaint is ¿manufacturing process design¿, since the design or validation of the manufacturing process was not sufficient to ensure the finished device met the intent of the design.There is an investigation in place to address this issue.A review of the device history record (dhr) was performed and no deviations were found.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 an unknown procedure performed on (b)(6) 2018.According to the complainant, during preparation, the brush failed to retract, and the bristled portion of the brush was noted to be bent.There were no patient complications reported as a result of this event.

• 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: 7293915
• MDR Text Key: 101010134
• Report Number: 3005099803-2018-00362
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2019
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 21346931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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