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

Model Number	M00555580
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2019
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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in lymph nodes during an endoscopic ultrasound fine needle aspiration (eus-fna) procedure performed on (b)(6) 2019.According to the complainant, while performing puncture during the procedure, resistance was met when slightly pulling out the stylet part of the inner catheter.The distal tip of the needle was found to be bent/broken.It was confirmed that the distal tip had broken/detached but remained inside the catheter of the device and therefore did not fall inside the patient's body.The procedure was completed using the original acquire needle.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in lymph nodes during an endoscopic ultrasound fine needle aspiration (eus-fna) procedure performed on (b)(6), 2019.According to the complainant, while performing puncture during the procedure, resistance was met when slightly pulling out the stylet part of the inner catheter.The distal tip of the needle was found to be bent/broken.It was confirmed that the distal tip had broken/detached but remained inside the catheter of the device and therefore did not fall inside the patient's body.The procedure was completed using the original acquire needle.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device problem code 2907 captures the reportable event of the tip of the needle detached.Block h10: investigation results an acquire eus fnb needle was received by boston scientific.Analysis of the returned device revealed that the needle returned broken in three section, one section was attached to the handle, another one was inside the sheath and the distal end was separated from the device.No other issues were noted.The distal section of the needle indicates that the device returned in good conditions, however likely procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Based on the information available and the analysis performed, the most probable cause is 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
• MDR Report Key: 9398672
• Report Number: 3005099803-2019-05828
• Device Sequence Number: 2133574
• Product Code: ODG
• UDI-Device Identifier: 08714729931829
• UDI-Public: 08714729931829
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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: 05/17/2022
• Device Model Number: M00555580
• Device Catalogue Number: 50277
• Device Lot Number: 0024170699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1