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

Model Number M00545000

Device Problems Mechanical Problem (1384); Retraction Problem (1536); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; 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 wireguided 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 device was inserted in the endoscope and cytology was planned to be performed.It was noticed on the endoscope screen that the catheter tip was damaged.The device was inserted into the bile duct once, and was reported to be difficult to extend and retract.To prevent the risk of bile duct injury, the device was removed from the patient.Examination of the device was done outside of the endoscope and the device was able to extend and retract but the catheter tip was noticed to be slightly flattened, and there seemed to be a part of the distal tip missing from the catheter.The procedure was completed with another rx cytology brush.Confirmation was received from the nurse stating that the missing part was not inside of the patient nor was it inside the sterile bag that the device was packed in.Reportedly, the catheter tip missing was noted soon after the device excited out of the distal tip of the scope.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.

• 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: 7961270
• MDR Text Key: 123691502
• Report Number: 3005099803-2018-60808
• 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: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00545000
• Device Catalogue Number: 49275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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