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

Model Number M00555560

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One eus fna needle was received by boston scientific.Analysis of the returned device revealed that the working length (sheath and needle) wa kinked at distal end of the handle with the sheath length adjust set at 1, also distal section of the working length was bent.During functional inspection the handle was actuated and the needle extended, once the needle was extended, it was observed that the needle tip was detached from the device.The detached distal needle tip was not received for analysis.No other issues were noted.It is most likely that anatomical or procedural factors encountered during the procedure could have caused the damages found on the device.Handling/manipulation of the device during its use can lead to kink/bent the working length (sheath and needle) near the handle and distal section, severe bending of the needle at distal section can result in needle breakage.All compiled information on this investigation determines that the most probable cause is adverse event related to procedure, since the adverse event occurred during the procedure and the device had no influence on event.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.

Event Description

It was reported to boston scientific corporation that an acquire eus fnb needle was used in the pancreas during a procedure performed on (b)(6) 2020.According to the complainant, during procedure the needle tip seemed to be very dull, therefore it was removed from the scope and another needle was used.The procedure was completed with another acquire eus fnb needle.There were no patient complications reported as a result of this event.The patient was fine.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the needle was detached.

• 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: 9905559
• MDR Text Key: 191301290
• Report Number: 3005099803-2020-01177
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 08714729931805
• UDI-Public: 08714729931805
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2022
• Device Model Number: M00555560
• Device Catalogue Number: 5556
• Device Lot Number: 0024436178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR