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

Model Number M00545000

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and 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 stenosis area in the bile duct for scraping cytology during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the radiopaque marker of the brush was noticed to be detached inside the bile duct.The physician attempted to remove and reposition the radiopaque marker from the bile duct into the duodenum by using a retrieval balloon.The physician was unsuccessful in doing so.The radiopaque marker was left inside the duodenum to pass naturally on its own.The procedure was completed with this device.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

Investigation results: a visual evaluation of the returned rx cytology brush revealed that the device was received in retracted position.Further evaluation noted that the catheter distal tip was found to be scraped or peeled off.The radiopaque marker was not present and was not returned for evaluation.It was also noted that indentation marks were found at the section of the device where the radiopaque marker is supposed to be located which indicates proper assembly during manufacturing process.The catheter was also torn at the distal tip.It is most likely that the tip of the device was possibly rubbed against the wall of the channel in the scope causing the paint to peel off; or due to the excessive manipulation of the device by the user during procedure.Also handling and manipulation of the device during its use could have generated the catheter getting torn at the distal end, once the distal end of the catheter was torn the radiopaque marker could have detached from the catheter.Based on all gathered information, the most probable cause of this complaint is ¿operational context¿, since it is most likely that due to anatomical and/or procedural factors encountered during the procedure the performance of the device was limited.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the stenosis area in the bile duct for scraping cytology during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the radiopaque marker of the brush was noticed to be detached inside the bile duct.The physician attempted to remove and reposition the radiopaque marker from the bile duct into the duodenum by using a retrieval balloon.The physician was unsuccessful in doing so.The radiopaque marker was left inside the duodenum to pass naturally on its own.The procedure was completed with this device.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: 7194734
• MDR Text Key: 97880141
• Report Number: 3005099803-2018-00031
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/13/2019
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 21128095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2017
• 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