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

Model Number	M00545000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Additional 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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was prepared for use in the bile duct during a endoscopic retrograde cholangiopancreatography (ercp) endoscopic lithotripsy procedure performed on (b)(6) 2021.It was reported that during preparation and outside the patient, the brush failed to extend after opening the package and the handle could not be pushed.The physician did not try to fully extend the device before use.No kinks were noted along the working length.No visual damage was noted in the handle.The procedure was discontinued and the target treatment was not completed.However, the physician did not inform on planning to complete the procedure since he estimated that the patient may not endure prolonged procedure although the patient has no complications.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: investigation results: an rx cytology brush was received for analysis.Visual inspection of the returned device revealed that the handle was severely kinked, therefore, handle actuation could not be performed.No other problems were noted.The reported complaint of handle break was not confirmed since the analysis performed determined that the handle wasn't broken.The kink observed on the handle may be related to user manipulation and/or some technique performed during the preparation of the device.Based on the provided and collected information, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process.Therefore, the most probable root cause for the reported complaint is adverse event related to procedure.This is defined as the adverse event occurred during the procedure and the device had no influence n event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was prepared for use in the bile duct during a endoscopic retrograde cholangiopancreatography (ercp) endoscopic lithotripsy procedure performed on (b)(6) 2021.It was reported that during preparation and outside the patient, the brush failed to extend after opening the package and the handle could not be pushed.The physician did not try to fully extend the device before use.No kinks were noted along the working length.No visual damage was noted in the handle.The procedure was discontinued and the target treatment was not completed.However, the physician did not inform on planning to complete the procedure since he estimated that the patient may not endure prolonged procedure although the patient has no complications.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

• Brand Name: RX CYTOLOGY BRUSH
• Common Device Name: 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: 13260486
• Report Number: 3005099803-2021-08228
• Device Sequence Number: 13878340
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K930348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2022
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0026364057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 73 KG