PIRANHA
Report
- Report Number
- 2124215-2024-15575
- Event Type
- Injury
- Date Received
- March 18, 2024
- Date of Event
- January 12, 2022
- Report Date
- April 23, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FCL
- UDI-DI
- 08714729302599
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF (B)(6) 2022, WAS CHOSEN AS THE BEST ESTIMATE BASED ON THE PROCEDURE WHICH HAPPENED SOMETIME IN 2022 AND 11 DAYS POST-PROCEDURE (POD11) ED PRESENTATION FOR INTERMITTENT CHEST PAIN. BLOCKS D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: PATIENT CODE E061201 CAPTURES THE REPORTABLE EVENT OF ANGINA. PATIENT CODE E233001 CAPTURES THE REPORTABLE EVENT OF CHEST PAIN. IMPACT CODE F12 CAPTURES THE REPORTABLE EVENT OF SERIOUS INJURY.
BLOCK H11: BLOCK A6 HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024. BLOCK B3: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF JANUARY 12, 2022, WAS CHOSEN AS THE BEST ESTIMATE BASED ON THE PROCEDURE WHICH HAPPENED SOMETIME IN 2022 AND 11 DAYS POST-PROCEDURE (POD11) ED PRESENTATION FOR INTERMITTENT CHEST PAIN. BLOCKS D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: PATIENT CODE E061201 CAPTURES THE REPORTABLE EVENT OF ANGINA. PATIENT CODE E233001 CAPTURES THE REPORTABLE EVENT OF CHEST PAIN. IMPACT CODE F12 CAPTURES THE REPORTABLE EVENT OF SERIOUS INJURY.
NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO EVENTS REPORTED BY THE SAME PATIENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING CYSTOURETHROSCOPY AND URETEROSCOPY WITH BIOPSY AND HOLMIUM LASER RESECTION OF LEFT RENAL PELVIS TUMOR PROCEDURE PERFORMED SOMETIME IN 2022. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. 11 DAYS POST-PROCEDURE (POD11), THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) FOR INTERMITTENT CHEST PAIN. THE PATIENT HAD SYMPTOMS SIGNIFICANT FOR UNSTABLE ANGINA STATUS POST CARDIAC CATHETERIZATION SHOWING NONOBSTRUCTIVE DISEASE. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS NOT RELATED TO THE DEVICE, AND POSSIBLY RELATED TO THE PROCEDURE.
NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO EVENTS REPORTED BY THE SAME PATIENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA BIOPSY FORCEPS WAS USED DURING CYSTOURETHROSCOPY AND URETEROSCOPY WITH BIOPSY AND HOLMIUM LASER RESECTION OF LEFT RENAL PELVIS TUMOR PROCEDURE PERFORMED SOMETIME IN 2022. DURING THE PROCEDURE, THE ACQUISITION OF THE BIOPSY SPECIMEN WAS ADEQUATE. 11 DAYS POST-PROCEDURE (POD11), THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) FOR INTERMITTENT CHEST PAIN. THE PATIENT HAD SYMPTOMS SIGNIFICANT FOR UNSTABLE ANGINA STATUS POST CARDIAC CATHETERIZATION SHOWING NONOBSTRUCTIVE DISEASE. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS NOT RELATED TO THE DEVICE, AND POSSIBLY RELATED TO THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2277228 | PIRANHA | FORCEPS, BIOPSY, NON-ELECTRIC | FCL | BOSTON SCIENTIFIC CORPORATION | M0065051600 | 08714729302599 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male | Other |