EMERGE?
Report
- Report Number
- 2124215-2025-28615
- Event Type
- Injury
- Date Received
- May 22, 2025
- Date of Event
- April 28, 2025
- Report Date
- July 7, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LOX
- UDI-DI
- 08714729806103
- PMA / PMN Number
- K113220
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PREMARKET / 510(K) #: K163174 DEVICE EVALUATED BY MFR.: FG EMERGE MR, US 2.50MM X 12MM, CATHETER WAS RETURNED FOR ANALYSIS. VISUAL, TACTILE AND MICROSCOPIC ANALYSIS WAS PERFORMED ON THE DEVICE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS ALONG THE SHAFT AND A BREAK AT 74CM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED NO TEARS OR PINHOLES IN THE BALLOON. A MICROSCOPIC EXAMINATION OF THE PROXIMAL AND DISTAL MARKERBANDS IDENTIFIED NO DAMAGE. A MICROSCOPIC EXAMINATION OF THE TIP SHOWED NO SIGNS OF TIP DAMAGE.
PREMARKET / 510(K) #: K163174.
IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE MIDDLE SHAFT WAS FRACTURED. THE DETACHED PORTION WAS COMPLETELY REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE MIDDLE SHAFT WAS FRACTURED. THE DETACHED PORTION WAS COMPLETELY REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1219746 | EMERGE? | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC CORPORATION | H7493918912250 | 0035465250 | 08714729806103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |