STERLING
Report
- Report Number
- 2124215-2023-62333
- Event Type
- Malfunction
- Date Received
- November 9, 2023
- Date of Event
- October 23, 2023
- Report Date
- July 3, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DQY
- UDI-DI
- 08714729756194
- PMA / PMN Number
- K141150
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E1: INITIAL REPORTER FACILITY: (B)(6) HOSPITAL. THIS REPORT IS BEING FILED TO CORRECT THE MODEL NUMBER AND UNIQUE IDENTIFIER (UDI) # IN RESPONSE TO AN FDA REQUEST.
E1: INITIAL REPORTER FACILITY: (B)(6) HOSPITAL.
IT WAS REPORTED THAT BALLOON DEFLATION SLOW AND DIFFICULTY REMOVAL OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED INTERNAL CAROTID ARTERY AND COMMON CAROTID ARTERY. A 5.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING PROCEDURE, THE BALLOON WAS SUCCESSFULLY INFLATED WITH ENCORE BSJ AT 6 ATMOSPHERES AND HELD THE PRESSURE FOR 30 SECONDS. HOWEVER, UPON POST-PROCEDURE, IT TOOK APPROXIMATELY 15 MINUTES TO REMOVE, AND DEFLATION WAS FOUR MORE TIMES THAN THE USUAL. THE DEVICE WAS REMOVED IN A DEFLATED STATE AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT INJURIES REPORTED.
IT WAS REPORTED THAT BALLOON DEFLATION SLOW AND DIFFICULTY REMOVAL OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED INTERNAL CAROTID ARTERY AND COMMON CAROTID ARTERY. A 5.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING PROCEDURE, THE BALLOON WAS SUCCESSFULLY INFLATED WITH ENCORE BSJ AT 6 ATMOSPHERES AND HELD THE PRESSURE FOR 30 SECONDS. HOWEVER, UPON POST-PROCEDURE, IT TOOK APPROXIMATELY 15 MINUTES TO REMOVE, AND DEFLATION WAS FOUR MORE TIMES THAN THE USUAL. THE DEVICE WAS REMOVED IN A DEFLATED STATE AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 92991 | STERLING | CATHETER, PERCUTANEOUS | DQY | BOSTON SCIENTIFIC CORPORATION | H74939031502010 | 0031851214 | 08714729756194 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | GUIDING CATHETER USED: OPTIMO 9F TOKAI MEDICAL| GUIDING CATHETER USED: OPTIMO 9F TOKAI MEDICAL| INTRODUCER SHEATH USED: 9F MEDIKIT| INTRODUCER SHEATH USED: 9F MEDIKIT |