EMERGE
Report
- Report Number
- 2124215-2024-75613
- Event Type
- Malfunction
- Date Received
- December 3, 2024
- Date of Event
- November 15, 2024
- Report Date
- February 12, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LOX
- UDI-DI
- 08714729806196
- PMA / PMN Number
- K113220
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B1: UPDATED ADVERSE EVENT/PRODUCT PROBLEM. B2: UPDATED OUTCOMES ATTRIB TO ADV EVENT. B5: DESCRIBE EVENT OR PROBLEM: UPDATED TO INCLUDE NEW INFORMATION OBTAINED. H1: UPDATED TYPE OF REPORTABLE EVENT. H6: IMPACT CODES: UPDATED IMPACT CODES. E1: INITIAL REPORTER: (B)(6). G4: PREMARKET / 510(K): K163174.
B1: UPDATED ADVERSE EVENT/PRODUCT PROBLEM B2: UPDATED OUTCOMES ATTRIB TO ADV EVENT B5: DESCRIBE EVENT OR PROBLEM: UPDATED TO INCLUDE NEW INFORMATION OBTAINED. H1: UPDATED TYPE OF REPORTABLE EVENT H6: IMPACT CODES: UPDATED IMPACT CODES. E1: INITIAL REPORTER ADDRESS 1: (B)(6) G4: PREMARKET / 510(K): K163174. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL, TACTILE, MICROSCOPIC AND WIRE INSERTION TESTING WERE PERFORMED ON THE DEVICE. VISUAL AND TACTILE INSPECTION OF HYPOTUBE AND SHAFT POLYMER EXTRUSION FOUND NO ISSUES. BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A MICROSCOPIC EXAMINATION OF THE PROXIMAL AND DISTAL MARKERBANDS IDENTIFIED NO DAMAGE. BUMPER TIP SHOWED NO SIGNS OF DISTAL TIP DAMAGE. THE INNER LUMEN WAS STRETCHED AT 4.6CM FROM THE DISTAL TIP. THE DEVICE COULD NOT BE FULLY LOADED AND TRACKED OVER A 0.014'' GUIDEWIRE DUE TO INNER LUMEN DAMAGE AT 4.6CM FROM DISTAL TIP. NO DEVICE ISSUES WERE IDENTIFIED DURING RETURNED PRODUCT ANALYSIS.
H6: IMPACT CODES: UPDATED IMPACT CODES. E1: INITIAL REPORTER ADDRESS 1: (B)(6). E1: INITIAL REPORTER PHONE: (B)(6). G4: PREMARKET / 510(K): K163174.
E1: INITIAL REPORTER ADDRESS 1: (B)(6). E1: INITIAL REPORTER PHONE: (B)(6) G4: PREMARKET / 510(K): K163174.
IT WAS REPORTED THAT A FROZEN GUIDEWIRE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT CORONARY ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING WITHDRAWAL, THE GUIDEWIRE BECAME STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE. IT WAS FURTHER REPORTED THAT THE DEVICE COULD NOT BE REMOVED NORMALLY DUE TO RESISTANCE AND WAS REMOVED THROUGH VARIOUS ATTEMPTED METHODS. IT WAS FURTHER REPORTED THAT THE DEVICE WAS SIMPLY REMOVED AS A WHOLE.
IT WAS REPORTED THAT A FROZEN GUIDEWIRE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT CORONARY ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING WITHDRAWAL, THE GUIDEWIRE BECAME STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE. IT WAS FURTHER REPORTED THAT THE DEVICE COULD NOT BE REMOVED NORMALLY DUE TO RESISTANCE AND WAS REMOVED THROUGH VARIOUS ATTEMPTED METHODS. IT WAS FURTHER REPORTED THAT THE DEVICE WAS SIMPLY REMOVED AS A WHOLE.
IT WAS REPORTED THAT A FROZEN GUIDEWIRE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT CORONARY ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING WITHDRAWAL, THE GUIDEWIRE BECAME STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE. IT WAS FURTHER REPORTED THAT THE DEVICE COULD NOT BE REMOVED NORMALLY DUE TO RESISTANCE AND WAS REMOVED THROUGH VARIOUS ATTEMPTED METHODS.
IT WAS REPORTED THAT A FROZEN GUIDEWIRE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT CORONARY ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING WITHDRAWAL, THE GUIDEWIRE BECAME STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1377965 | EMERGE | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC CORPORATION | H7493918915200 | 0034034167 | 08714729806196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female | Required Intervention |