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

Model Number M00545000

Device Problems Break (1069); Defective Device (2588); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an rx cytology brush wireguided was prepped for use for an endoscopic retrograde cholangiopancreatography (ercp) procedure to be performed in the bile duct on (b)(6) 2019.According to the complainant, during preparation prior to the procedure, it was noted that the brush was not uniform and the bristles were not in order.The procedure was completed with another rx cytology brush.There was no serious injury nor were there any adverse patient effects reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.

Manufacturer Narrative

Initial reporter facility and address: (b)(6) hospital.Device problem code 2981 captures the reportable event of brush bent.Visual analysis of the returned device revealed that the working length (extrusion and pull wire) was kinked approximately at 19cm from the black heat shrink.The handle was kinked and broken (thumb ring separated from handle cannula), broken end had evidence of bending.Functional analysis revealed that the brush was unable to extend when the handle cannula was moved simulating the handle actuation.The device was disassembled and it was observed that the pull wire was kinked adjacent to the handle cannula joint.No other issues were noted.It is most likely that handling or manipulation of the device during unpacking/prepping/testing could have affected the device integrity.Likely the failures found (working length kinked, handle kinked/broken) were caused due to manipulation as the customer brushed back and forth during testing/prepping.Handling and manipulation of the device can lead to kinking of the catheter and pull wire, this condition can cause difficulties to extend the brush, force applied to the handle in order to extend the brush can result in bending the handle and kinking the pull wire at handle cannula joint, continued attempts to move the handle can result in handle breakage.Based on the information available and the analysis performed, the investigation conclusion code for the encountered damages will be documented as "adverse event related to procedure." in addition, the pull wire was completely removed from the device in order to inspect the bristle section, no visual issues were observed with the bristle section; consequently, not confirming the reported issue, therefore the investigation conclusion code for the reported event "when the device was prepared, brush was not uniform, and its hair was not in order." will be documented as "no problem detected" since the device complaint or problem cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

Event Description

It was reported to boston scientific corporation that an rx cytology brush wireguided was prepped for use for an endoscopic retrograde cholangiopancreatography (ercp) procedure to be performed in the bile duct on (b)(6) 2019.According to the complainant, during preparation prior to the procedure, it was noted that the brush was not uniform and the bristles were not in order.The procedure was completed with another rx cytology brush.There was no serious injury nor were there any adverse patient effects reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.

• 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: 8540437
• MDR Text Key: 142779958
• Report Number: 3005099803-2019-02116
• 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: 06/12/2019

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: 01/15/2021
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0023196845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1