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

Model Number	M00555540
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in the duodenal bulb during an endoscopic ultrasound fine-needle biopsy (eus-fnb) procedure performed on (b)(6) 2022.During the procedure, the needle would not extend.The patient was sedated when the event occurred.The procedure was not completed successfully.There were no patient complications reported as a result of the event.The patients condition following the procedure was reported to be stable.
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 emdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in the duodenal bulb during an endoscopic ultrasound fine-needle biopsy (eus-fnb) procedure performed on (b)(6), 2022.During the procedure, the needle would not extend.The patient was sedated when the event occurred.The procedure was not completed successfully.There were no patient complications reported as a result of the event.The patients condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block d4: lot number updated based on device received.Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: investigation results the returned acquire needle was analyzed, and a visual evaluation noted that the working length was found kinked at the proximal section and the needle was retracted.A functional evaluation noted that some resistance was felt during the extension the needle.No other issues were noted.The reported complaint was confirmed.Based on all available information and the condition of the returned device, it is possible that evidence of over manipulation against this unit caused the working length to kink and not allow the needle to extend as it should.It is possible that factors and/or conditions related to the procedure during the use of the device could have affected its performance and its intended purpose.Therefore, the investigation concluded the most probable root cause as adverse event related to procedure.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.

• 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: 14147948
• Report Number: 3005099803-2022-01891
• Device Sequence Number: 16879893
• Product Code: ODG
• UDI-Device Identifier: 08714729931782
• UDI-Public: 08714729931782
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 06/01/2022

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: 10/24/2024
• Device Model Number: M00555540
• Device Catalogue Number: 5554
• Device Lot Number: 0028260349
• 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: 03/25/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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