ACQUIRE
Report
- Report Number
- 3005099803-2025-00273
- Event Type
- Malfunction
- Date Received
- January 30, 2025
- Date of Event
- January 1, 2025
- Report Date
- November 24, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FCG
- UDI-DI
- 08714729931782
- PMA / PMN Number
- K160845
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK A2: PATIENT'S DATE OF BIRTH AND EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK D2B: ADDITIONAL PRO CODE (PRODUCT CODE) - ODG BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF NEEDLE DETACHMENT OF DEVICE OR DEVICE COMPONENT.
BLOCK A2: PATIENT'S DATE OF BIRTH AND EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK D2B: ADDITIONAL PRO CODE (PRODUCT CODE) - ODG. BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF NEEDLE DETACHMENT OF DEVICE OR DEVICE COMPONENT. BLOCK H11: THE RETURNED ACQUIRE BIOPSY NEEDLE WAS ANALYZED, AND A PRODUCT ANALYSIS FOUND THE HANDLE BROKEN. THE WORKING LENGTH WAS OBSERVED KINKED AND BENT. THE NEEDLE WAS FOUND NOT BROKEN BUT KINKED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED NEEDLE DETACHMENT OF DEVICE OR DEVICE COMPONENT WAS NOT CONFIRMED. THE HANDLE WAS RETURNED BROKEN; THIS WAS CAUSED BY EXCESSIVE FORCE WHEN INSERTING THE DEVICE INTO THE SCOPE OR BY EXCESSIVE MANIPULATION OF THE DEVICE DURING THE PROCEDURE. THIS DAMAGE ALSO CAUSED THE NEEDLE INSIDE THE HANDLE TO KINK. ALSO, THE WORKING LENGTH WAS OBSERVED BENT AND KINKED. PROCEDURAL OR ANATOMICAL CONDITIONS COULD HAVE AFFECTED THE DEVICE'S PERFORMANCE AND INTEGRITY. IT IS LIKELY THESE EVENTS WERE CAUSED BY OPERATIONAL FACTORS SUCH AS HANDLING, TECHNIQUE, OR DEVICE MANIPULATION. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE BECAUSE THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON EVENT. SINCE THE REPORTED NEEDLE DETACHMENT OF DEVICE OR DEVICE COMPONENT COULDN'T BE CONFIRMED DURING ANALYSIS THIS EVENT WILL BE ADDRESSED AS NO PROBLEM DETECTED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE EUS FNA NEEDLE WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN FROM THE SHEATHE HUB IN THE MIDDLE OF THE NEEDLE. THE MIDDLE PART OF THE NEEDLE COMPLETELY GOT BROKEN AND DETACHED OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE EUS FNA NEEDLE WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN FROM THE SHEATHE HUB IN THE MIDDLE OF THE NEEDLE. THE MIDDLE PART OF THE NEEDLE COMPLETELY GOT BROKEN AND DETACHED OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2230632 | ACQUIRE | BIOPSY NEEDLE | FCG | BOSTON SCIENTIFIC CORPORATION | M00555540 | 0034549666 | 08714729931782 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |