ZERO TIP
Report
- Report Number
- 2124215-2024-48184
- Event Type
- Malfunction
- Date Received
- August 9, 2024
- Date of Event
- July 17, 2024
- Report Date
- December 4, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FFL
- UDI-DI
- 08714729469643
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF BASKET WIRE BREAK.
BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK H2: ADDITIONAL INFORMATION: BLOCK B5 (DESCRIBE EVENT OR PROBLEM). BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF BASKET WIRE BREAK.
BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF BASKET WIRE BREAK. BLOCK H11: INVESTIGATION RESULTS THE RETURNED ZERO TIP BASKET WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE DEVICE RETURNED WITH THE BASKET ON ITS OPEN POSITION. IT WAS ALSO NOTED THAT THE HANDLE RETURNED IN GOOD CONDITION. MEDIA ANALYSIS SHOWS WITH THE PICTURE PROVIDED BY THE CUSTOMER THAT ONE OF THE BASKETS WAS BROKEN. MICROSCOPIC EXAMINATION WAS PERFORMED UNDER MAGNIFICATION, AND IT WAS POSSIBLE TO SEE THAT ONE OF THE BASKET WIRES WAS BROKEN AND WAS NOT FULLY DETACHED. FUNCTIONAL EXAMINATION WAS PERFORMED, AND THE HANDLE WAS ACTUATED. ADDITIONALLY, THE BASKET WAS ABLE TO OPEN AND CLOSE. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT OF BASKET WIRE BREAK WAS CONFIRMED. BASED ON THE INVESTIGATION RESULTS THIS COULD BE RELATED TO HANDLING AND MANIPULATION OF THE DEVICE DURING PROCEDURE, IT IS PROBABLE THAT AN EXCESS OF FORCE APPLIED TO THE DEVICE SUCH AS OPERATIONAL FACTORS DURING THEIR USE COULD LEAD TO BREAK THE BASKET WIRE. THE DEVICE MEETS ALL MANUFACTURING SPECIFICATIONS REQUIRED AND PASSED ALL THE CONTROLS AND INSPECTIONS; NO ABNORMALITIES WERE REPORTED DURING THE ASSEMBLY PROCESS. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE MOST PROBABLE CAUSE OF THIS COMPLAINT IS ADVERSE EVENT RELATED TO PROCEDURE BECAUSE THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON THE EVENT.
IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE. DURING THE PROCEDURE, THE BASKET GOT DAMAGED INSIDE THE PATIENT. REPORTEDLY, THEY WERE ABLE TO REMOVE THE DEVICE OUT OF PATIENT AND NO BASKET PIECE LEFT INSIDE THE PATIENT BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE. DURING THE PROCEDURE, THE BASKET WIRE GOT DAMAGED AND BROKEN. ADDITIONALLY, THERE WAS NO PIECES OF THE DEVICE WAS LEFT IN THE PATIENT BODY. REPORTEDLY, THEY WERE ABLE TO REMOVE THE BASKET USING A HAND PIECE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE. DURING THE PROCEDURE, THE BASKET WIRE GOT DAMAGED AND BROKEN. ADDITIONALLY, THERE WAS NO PIECES OF THE DEVICE WAS LEFT IN THE PATIENT BODY. REPORTEDLY, THEY WERE ABLE TO REMOVE THE BASKET USING A HAND PIECE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2247077 | ZERO TIP | DISLODGER, STONE, BASKET, URETERAL, METAL | FFL | BOSTON SCIENTIFIC CORPORATION | M0063901050 | 0033428215 | 08714729469643 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |