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

Model Number M00555540

Device Problems Mechanical Problem (1384); Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an acquire needle was used during an unknown procedure.During the procedure, the needle was difficult to extend and retract.The procedure was canceled due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Impact code f1001 captures the reportable event of cancelled procedure.

Event Description

It was reported to boston scientific corporation that an acquire needle was used during an endoscopic ultrasound fine needle aspiration (eus-fna) procedure.During the procedure, the needle was difficult to extend and retract.The procedure was canceled due to this event.There were no patient complications reported as a result of this event.

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 h6: impact code f1001 captures the reportable event of cancelled procedure.Block h10: investigation results: the returned acquire needle was analyzed.The visual evaluation found that the working length was kinked, and the stylet was returned loaded.The device was actuated, and the needle extended and retracted with resistance.In addition, the handle was disassembled, and the needle was found kinked.No other problems were noted.The reported event was confirmed.Product analysis identified that the working length and the needle were found kinked.Most likely the working length and needle got kinked/bent due to some operational and anatomical factors encountered during the procedure.Once the device is kinked/bent this condition could have generated resistance to extended and retracted the needle.Based on all available information and analysis of the returned device, the most probable cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.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 instructions for use (ifu) / product label.Block h11: additional information: block b5 has been updated based on the additional information that an acquire needle was used during an endoscopic ultrasound fine needle aspiration (eus-fna) procedure.

• Brand Name: ACQUIRE
• Type of Device: 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: 16612994
• MDR Text Key: 312040735
• Report Number: 3005099803-2023-01482
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 08714729931782
• UDI-Public: 08714729931782
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00555540
• Device Catalogue Number: 5554
• Device Lot Number: 0030366831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1