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

Model Number	M00555540
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
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 emdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an acquired eus fnb needle was used during an endoscopic ultrasound (eus) procedure performed on (b)(6), 2020.According to the complainant, during the procedure, there was an issue with the device; however, detail about the issue are unknown.Reportedly, the procedure was not completed successfully.There were no patient complications reported as a result of this event.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: device problem code 3191 is being used to capture the reportable issue of procedure not completed successfully.Block h10: investigation results the returned acquire eus fnb needle was analyzed, and a visual evaluation noted that the working length (needle and sheath) was kinked approximately at 3cm from distal end.A functional evaluation noted that the stylet was not able to advance due to the needle kinked at distal section.Based on all available information and the condition of the returned device, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Handling and manipulation of the device during the procedure could have led to the kink at distal section of the device and once the needle is kinked, it would cause issues to advance the stylet through the kinked section.The investigation concluded the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an acquire eus fnb needle was used during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, there was an issue with the device, however detail about the issue are unknown.Reportedly, the procedure was not completed successfully.There were no patient complications reported as a result of this event.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 10197194
• Report Number: 3005099803-2020-02496
• Device Sequence Number: 2392634
• Product Code: ODG
• UDI-Device Identifier: 08714729931782
• UDI-Public: 08714729931782
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K160845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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: 12/18/2022
• Device Model Number: M00555540
• Device Catalogue Number: 5554
• Device Lot Number: 0024957301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 08/06/2020
• Patient Sequence Number: 1