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 08/05/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental emdr will be filed.

Event Description

It was reported to boston scientific corporation that an acquire needle was used in the biliary tree during a liver biopsy procedure performed on (b)(6) 2021.During the procedure, the physician was pushing the needle catheter and felt resistance.A piece of clear plastic with the words "sterile" on it popped out of the working channel of the scope.They took the needle out of the scope and grabbed the plastic using forceps.It is unclear if the plastic came from the scope or the needle catheter.The procedure was completed with another acquire needle.No patient complications were 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: 15341538
• MDR Text Key: 302071267
• Report Number: 3005099803-2022-04830
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2022

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: M00555580
• Device Catalogue Number: 50277
• Device Lot Number: 0029338152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• 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