EMERGE
Report
- Report Number
- 2124215-2024-69554
- Event Type
- Malfunction
- Date Received
- November 5, 2024
- Date of Event
- October 28, 2024
- Report Date
- January 8, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LOX
- UDI-DI
- 08714729806325
- PMA / PMN Number
- K113220
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G4: PMA/510(K) #: K163174.
G4: PMA/510(K) #: K163174. DEVICE EVALUATED BY MFR.: THE FG EMERGE MR, US 2.50MM X 20MM, WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE FOR ANALYSIS. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT IDENTIFIED A BREAK 80.5CM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF, THE DETACHED SECTION OF THE SHAFT WAS NOT RETURNED. THE DISTAL SHAFT INCLUDING POLYMER EXTRUSION WAS NOT RETURNED WITH THE DEVICE. NO OTHER DEVICE ISSUES WERE IDENTIFIED DURING RETURNED PRODUCT ANALYSIS.
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BROKE. THE PROCEDURE COMPLETED USING AN ALTERNATE METHOD AND NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BROKE. THE PROCEDURE COMPLETED USING AN ALTERNATE METHOD AND NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2132749 | EMERGE | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC CORPORATION | H7493918920250 | 0033506371 | 08714729806325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |