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

Model Number M00555560

Device Problems Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that an acquire needle was used in pancreas during an endoscopic ultrasound-guided fine-needle aspiration (eus-fna) procedure performed on (b)(6) 2022.During the procedure, it was attempted to pull the stylet and severe resistance was felt while pulling the stylet out.The device was flushed with saline solution after one specimen was collected, however, a black rust-like substance came out from the tip of the needle.The procedure was completed with another acquire needle there were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: device code a180104 captures the reportable event of foreign material.Block h10: investigation results the returned acquire needle was analyzed, a visual evaluation was performed and no damages or additional defects were found.A functional evaluation noted that the stylet was removed and reinserting without problems.No other problems were noted.Based on all available information and the condition of the returned device, it is not possible to confirm the material properties to determine where this residue comes from.The investigation concluded the most probable cause is cause not established.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that an acquire needle was used in pancreas during an endoscopic ultrasound-guided fine-needle aspiration (eus-fna) procedure performed on (b)(6) 2022.During the procedure, it was attempted to pull the stylet and severe resistance was felt while pulling the stylet out.The device was flushed with saline solution after one specimen was collected, however, a black rust-like substance came out from the tip of the needle.The procedure was completed with another acquire needle.There were no patient complications reported as a result of this event.

• 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: 15828864
• MDR Text Key: 307107370
• Report Number: 3005099803-2022-06692
• Device Sequence Number: 1
• Product Code: ODG
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

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
• Device Operator: Health Professional
• Device Model Number: M00555560
• Device Catalogue Number: 5556
• Device Lot Number: 0029668752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2022
• 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