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

Model Number M00545000

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2018

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).An rx cytology brush was returned for evaluation.A visual evaluation found the working length (extrusion and wire) is kinked in several locations, also the distal section of the device (brush section) is bent.Analysis of the returned device revealed that the brush extension and retraction were measured and both dimensions were found to be within specifications.During the functional inspection the brush was able to extend and retract, however, there was resistance due to the working length (extrusion and wire) being kinked in several locations.In addition, the distal section of the device (brush section) was bent which could have cause some difficulty at the moment to extend/retract the brush.The damages noted with the returned device were most likely that handling and manipulation of the device could have contributed with the encountered damages.Likely the failures found (working length (extrusion and wire) kinked and brush section bent) were caused due to excessive manipulation as the customer tested the device during preparation.Handling and manipulation of the device can lead to kink the extrusion and wire, this condition can cause difficulties to extend/retract the brush due to friction generated between extrusion and wire at kinked/bent areas.Based on the information available and the analysis performed, the most probable root cause classification is cause traced to component failure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a rx cytology brush wireguided was to be used in the distal bile duct for a brush cytology procedure for diagnosis of suspected pancreatic cancer performed on (b)(6) 2018.According to the complainant, during preparation and outside the patient, the brush could not be retracted.The procedure was completed with another cytology brush.There was no serious injury nor any adverse patient effects reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the distal section of the device (brush section) was bent.

• Brand Name: RX CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8206542
• MDR Text Key: 131765351
• Report Number: 3005099803-2018-62341
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 12/31/2018

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: 05/14/2020
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0022120670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2018
• 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