CAPTIVATOR
Report
- Report Number
- 3005099803-2023-03478
- Event Type
- Malfunction
- Date Received
- June 30, 2023
- Date of Event
- April 10, 2023
- Report Date
- July 20, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FDI
- UDI-DI
- 08714729019336
- PMA / PMN Number
- K131700
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK D4, H4: THE SUSPECT DEVICE LOT NUMBER WAS NOT REPORTED; HOWEVER ADDITIONAL INFORMATION RECEIVED ON JULY 4, 2023 STATING THE MANUFACTURE DATE WAS JUNE 6, 2022 AND THE EXPIRATION DATE IS ON JUNE 6, 2025. BLOCK E1: (INITIAL REPORTER CITY) (B)(6). BLOCK H6: IMDRF DEVICE CODE A050702 CAPTURES THE REPORTABLE EVENT OF LOOP CUTTING PROBLEMS.
BLOCK D4, H4: THE SUSPECT DEVICE LOT NUMBER WAS NOT REPORTED; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK E1: (INITIAL REPORTER CITY) (B)(6). BLOCK H6: IMDRF DEVICE CODE A050702 CAPTURES THE REPORTABLE EVENT OF LOOP CUTTING PROBLEMS.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS USED TO RESECT A 0.6CM POLYP IN THE DESCENDING COLON DURING AN INTESTINAL POLYP REMOVAL PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE WAS A PROBLEM WITH THE ELECTRIC SNARE'S CLOSURE WHEN IT WAS TIGHTENED. IT WAS NOT POSSIBLE TO COMPLETELY REMOVE THE POLYP, AND THERE WAS EXCESSIVE BURNING OF THE SURROUNDING INTESTINAL MUCOSA. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIVATOR MEDIUM OVAL STIFF SNARE. THERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS USED TO RESECT A 0.6CM POLYP IN THE DESCENDING COLON DURING AN INTESTINAL POLYP REMOVAL PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE WAS A PROBLEM WITH THE ELECTRIC SNARE'S CLOSURE WHEN IT WAS TIGHTENED. IT WAS NOT POSSIBLE TO COMPLETELY REMOVE THE POLYP, AND THERE WAS EXCESSIVE BURNING OF THE SURROUNDING INTESTINAL MUCOSA. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIVATOR MEDIUM OVAL STIFF SNARE. THERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1254220 | CAPTIVATOR | SNARE, FLEXIBLE | FDI | BOSTON SCIENTIFIC CORPORATION | M00562321 | 08714729019336 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |