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

Model Number	M00555580
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in the liver during an endoscopic retrograde cholangiopancreatography performed on (b)(6), 2023.During the procedure, the needle was flushed with heparin prior to insertion for liver biopsy.The technician noticed black materials flushing out from the tip of the needle.The procedure was completed using another acquire needle.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in the liver during an endoscopic retrograde cholangiopancreatography performed on (b)(6) 2023.During the procedure, the needle was flushed with heparin prior to insertion for liver biopsy.The technician noticed black materials flushing out from the tip of the needle.The procedure was completed using another acquire needle.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Imdrf device code (b)(4) captures the reportable event of foreign material present in device.Investigation results the returned acquire needle was analyzed and showed no visible damage.The stylet was not returned with the device.Based on media analysis of the photo provided by the customer, it is possible to see some black residue.A functional evaluation was performed, and black residue came from inside the needle when the device was flushed.Based on all the information available, the reported event was confirmed.An investigation to address this problem is in progress; therefore, the root cause of the event is conclusion not yet available.Report source has been corrected.

• Brand Name: ACQUIRE
• Common Device Name: 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: 17794336
• Report Number: 3005099803-2023-04961
• Device Sequence Number: 18015137
• Product Code: ODG
• UDI-Device Identifier: 08714729931829
• UDI-Public: 08714729931829
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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: 06/09/2026
• Device Model Number: M00555580
• Device Catalogue Number: 50277
• Device Lot Number: 0031793425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown