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

Model Number M00555580

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/28/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.

Event 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.

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
• 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: 17794336
• MDR Text Key: 324016124
• Report Number: 3005099803-2023-04961
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 08714729931829
• UDI-Public: 08714729931829
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2023
• 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