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

Model Number M00545000

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2017

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 an rx cytology brush was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, there was difficulty in advancing the brush through the common bile duct.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Visual evaluation of the returned device found that the catheter and the wire were kinked in multiple locations throughout.The bristled portion of the brush does not present any visual issue.Functional analysis revealed that the device extends and retracts with resistance felt due to the kinks found on the device.Dimensional inspection was performed and found that the device was within specification.Based on the evaluation of the returned device, these failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.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 the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, there was difficulty in advancing the brush through the common bile duct.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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: 6959314
• MDR Text Key: 90596122
• Report Number: 3005099803-2017-03087
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/12/2015
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 15943936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2013
• 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