EMERGE?
Report
- Report Number
- 2124215-2025-23568
- Event Type
- Malfunction
- Date Received
- April 17, 2025
- Date of Event
- March 4, 2025
- Report Date
- May 5, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LOX
- UDI-DI
- 08714729806103
- PMA / PMN Number
- K113220
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Narratives
E1 - INITIAL REPORTER CITY: (B)(6). G4 - PREMARKET #: K163174.
E1 - INITIAL REPORTER CITY: (B)(6). G4 - PREMARKET #: K163174.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.50MM X 12MM EMERGE? BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT STENOSIS WAS 80% OF THE TARGET LESION AND LOCATED IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE BALLOON WAS INFLATED ONCE AND BURST DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR 10 SECONDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT'S STATUS WAS STABLE.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.50MM X 12MM EMERGE? BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1776698 | EMERGE? | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC CORPORATION | H7493918912250 | 0033637704 | 08714729806103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Female |