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

Model Number	M00555561
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Obtain Sample (2533); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in the mediastinal node during a fine needle biopsy procedure performed on an unknown date.During the procedure, the needle could not puncture into the node because the node was too small.The procedure was aborted.There were no patient complications reported as a result of this event.There is currently no date set to reschedule the procedure.
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Initial reporter name and address: physicians first name: (b)(6).(b)(4).
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block e1: physicians first name: (b)(6) block h6: impact code f1001 captures the reportable event of procedure aborted.Block h10: investigation results the returned acquire needle was analyzed, a visual evaluation was performed and the working length was kinked.A functional evaluation noted that the stylet could not move forward due to the kink.No other problems were noted.Based on the available information, it is possible that factors and/or conditions related to procedure during the use of the device could have affected its performance and its intended purpose.Therefore, based on all gathered information, the complaint investigation conclusion code selected is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in the mediastinal node during a fine needle biopsy procedure performed on an unknown date.During the procedure, the needle could not puncture into the node because the node was too small.The procedure was aborted.There were no patient complications reported as a result of this event.There is currently no date set to reschedule the procedure.

• Brand Name: ACQUIRETM
• 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: 15567400
• Report Number: 3005099803-2022-05657
• Device Sequence Number: 20323307
• Product Code: ODG
• UDI-Device Identifier: 08714729931867
• UDI-Public: 08714729931867
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 11/10/2022

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: 03/23/2025
• Device Model Number: M00555561
• Device Catalogue Number: 50278
• Device Lot Number: 0029101691
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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