MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACQUIRE; ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY

Model Number	M00555540
Medical Device Problem Codes	Defective Device (2588); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used during an endoscopic ultrasound fine needle aspiration (eus-fna) procedure on (b)(6) 2024.During withdrawal of the acquire needle, the luer attachment was unable to unlock from the endoscope.The endoscope along with the stuck needle were removed from the patient.The specimen was collected from the needle of the device.The endoscope was sent for repair to remove the acquire needle.The procedure was canceled due to this event.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: impact code f1001 captures the reportable event of cancelled procedure.
Additional Manufacturer Narrative
Block h6: impact code f1001 captures the reportable event of cancelled procedure.Block h11: the returned acquire needle was analyzed, and a product analysis observed that the working length is kinked right next to the luer.The luer was found bent.The reported event was confirmed.Based on all available information, it is possible that the technique used was possibly the reason why the working length was found kinked.When the handle is not grabbed or secured carefully, the weight of the device itself can bend the working length.Additionally, if excessive force is being used to grab any of the components of the device, this can lead to problems seen.It is also a possibility that the device was grabbed with too much force when it was being tighten to the scope.Additionally, it was reported that the procedure was cancelled due to conditions reported on the complaint.Since it was reported that the device wasn't able to be used and the procedure was cancelled, this event will be addressed as adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used during an endoscopic ultrasound fine needle aspiration (eus-fna) procedure on (b)(6) 2024.During withdrawal of the acquire needle, the luer attachment was unable to unlock from the endoscope.The endoscope along with the stuck needle were removed from the patient.The specimen was collected from the needle of the device.The endoscope was sent for repair to remove the acquire needle.The procedure was canceled due to this event.There were no patient complications as a result of this event.

• Brand Name: ACQUIRE
• Common Device Name: ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
• 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: 19287661
• Report Number: 3005099803-2024-02144
• Device Sequence Number: 20618582
• Product Code: ODG
• UDI-Device Identifier: 08714729931782
• UDI-Public: 08714729931782
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160845
• 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): 10/31/2024

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: 04/18/2026
• Device Model Number: M00555540
• Device Catalogue Number: 5554
• Device Lot Number: 0031460423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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 Sex: Unknown