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 Consequences Or Impact To Patient (2199)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an acquire eus fnb needle was used during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2020.According to the complainant, during preparation they flushed the needle with saline before introducing it to the patient.During the flush, they noticed there were black remnants that came out from the catheter.The procedure was completed with another acquire eus fnb 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: 9785172
• MDR Text Key: 190820025
• Report Number: 3005099803-2020-00546
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2023
• Device Model Number: M00555580
• Device Catalogue Number: 50277
• Device Lot Number: 0025041354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2020
• 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