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 03/05/2018

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 an rx cytology brush was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the brush was difficult to advance through the common bile duct and it was noted that the device failed to extend out of the catheter.The catheter was removed and a stent was placed.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Investigation results: a rx cytology brush was received for analysis.A visual evaluation of the returned device revealed that it was received in retracted position.Further evaluation noted that the working length (pull wire and extrusion) was kinked in several locations.A functional analysis was performed and revealed that the brush was not able to extend due to the kinks found on the device.The reported event that the device was difficult to advance through the common bile duct could not be confirmed; however, the investigation did confirm the reported event that the brush failed to extend out of the catheter.It is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Likely the failure found, (working length kinked) was caused due to excessive manipulation as the customer brushed back and forth the device during procedure.Handling and manipulation of the device can lead to the catheter and pull wire being kinked; this condition can cause resistance during the brush extension/retraction.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 confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.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) 2018.According to the complainant, during the procedure, the brush was difficult to advance through the common bile duct and it was noted that the device failed to extend out of the catheter.The catheter was removed and a stent was placed.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 7341969
• MDR Text Key: 102583792
• Report Number: 3005099803-2018-00790
• 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: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 20026230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2016
• 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