EMERGE?
Report
- Report Number
- 2124215-2025-64579
- Event Type
- Malfunction
- Date Received
- September 22, 2025
- Date of Event
- July 2, 2025
- Report Date
- December 11, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LOX
- UDI-DI
- 08714729806189
- PMA / PMN Number
- K121196
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E1 - INITIAL REPORTER EMAIL. G4 - PREMARKET: K163174. DEVICE EVALUATED BY MFR.: THE DEVICE FG EMERGE MR, US 1.50MM X 15MM WAS RETURNED FOR ANALYSIS. VISUAL, TACTILE, MICROSCOPIC AND WIRE INSERTION ANALYSIS WAS PERFORMED ON THE DEVICE. NO ISSUES WERE NOTED ON THE BALLOON PROFILE. A KINK WAS IDENTIFIED ON THE HYPOTUBE, 25.2CM DISTAL TO THE DISTAL END OF THE STAIN RELIEF. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED NO TEARS OR PINHOLES IN THE BALLOON. MICROSCOPIC EXAMINATION OF THE SHAFT IDENTIFIED A PROLAPSED AND STRETCHED INNER WIRE LUMEN, 6.5CM FROM TIP OF DEVICE WITH A PROTRUDING OUTER LUMEN, 7CM FROM THE TIP. TIP SHOWED NO SIGNS OF TIP DAMAGE. A MICROSCOPIC EXAMINATION OF THE PROXIMAL AND DISTAL MARKERBANDS IDENTIFIED NO DAMAGE. THE DEVICE COULD NOT BE LOADED OR TRACKED ON A TEST GUIDEWIRE DUE TO THE DAMAGE ON THE INNER WIRE LUMEN. NO OTHER DEVICE ISSUES WERE IDENTIFIED DURING RETURNED PRODUCT ANALYSIS.
G4 - PREMARKET: K163174. DEVICE EVALUATED BY MFR.: THE DEVICE FG EMERGE MR, US 1.50MM X 15MM WAS RETURNED FOR ANALYSIS. VISUAL, TACTILE, MICROSCOPIC AND WIRE INSERTION ANALYSIS WAS PERFORMED ON THE DEVICE. NO ISSUES WERE NOTED ON THE BALLOON PROFILE. A KINK WAS IDENTIFIED ON THE HYPOTUBE, 25.2CM DISTAL TO THE DISTAL END OF THE STAIN RELIEF. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED NO TEARS OR PINHOLES IN THE BALLOON. MICROSCOPIC EXAMINATION OF THE SHAFT IDENTIFIED A PROLAPSED AND STRETCHED INNER WIRE LUMEN, 6.5CM FROM TIP OF DEVICE WITH A PROTRUDING OUTER LUMEN, 7CM FROM THE TIP. TIP SHOWED NO SIGNS OF TIP DAMAGE. A MICROSCOPIC EXAMINATION OF THE PROXIMAL AND DISTAL MARKERBANDS IDENTIFIED NO DAMAGE. THE DEVICE COULD NOT BE LOADED OR TRACKED ON A TEST GUIDEWIRE DUE TO THE DAMAGE ON THE INNER WIRE LUMEN. NO OTHER DEVICE ISSUES WERE IDENTIFIED DURING RETURNED PRODUCT ANALYSIS.
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26AUG2025. IT WAS REPORTED THAT DIFFICULTY TRACKING OVER THE WIRE WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. THE 1.50MM X 15MM EMERGE? BALLOON CATHETER WAS ADVANCED. HOWEVER, DURING INSERTION, THE GUIDEWIRE COULD NOT CROSS THE PORT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE POST-PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A TEAR ON THE OUTER LUMEN.
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26AUG2025. IT WAS REPORTED THAT DIFFICULTY TRACKING OVER THE WIRE WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. THE 1.50MM X 15MM EMERGE? BALLOON CATHETER WAS ADVANCED. HOWEVER, DURING INSERTION, THE GUIDEWIRE COULD NOT CROSS THE PORT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE POST-PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A TEAR ON THE OUTER LUMEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1959985 | EMERGE? | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC CORPORATION | H7493918915150 | 0034344414 | 08714729806189 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female |