EMERGE?
Report
- Report Number
- 2124215-2026-07515
- Event Type
- Malfunction
- Date Received
- February 11, 2026
- Date of Event
- January 20, 2026
- Report Date
- March 20, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LOX
- PMA / PMN Number
- K130391
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- 003
Narratives
G4 PREMARKET / 510(K): K163174. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. INVESTIGATION RESULTS: DEVICE TECHNICAL ANALYSIS: THE DEVICE WAS NOT RETURNED; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD REVIEW: IT WAS CONFIRMED THAT THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE ARE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. RISK REVIEW: A RISK REVIEW WAS PERFORMED, AND IT CONFIRMED THAT THE EVENT WAS DEFINED IN THE RISK DOCUMENTATION AND IS RECORDED ACCORDINGLY IN THE PRODUCT RECORD REVIEW (PRR) TABLE. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: THIS INVESTIGATION IS ASSIGNED A MOST PROBABLE INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED, BASED ON THE LIMITED INFORMATION WITHIN THE EVENT. THIS CODE WAS SELECTED AS THE MOST PROBABLE COMPLAINT CAUSE BASED ON THE INFORMATION AVAILABLE. THE COMPLAINT REPORTED THAT THE DEVICE WAS FRACTURED/SEPARATED. AS THE COMPLAINT REPORTED THAT THE DEVICE WAS DISPOSED AND IT DID NOT RETURN TO THE CIS FOR ANALYSIS THE REPORTED ALLEGATION CANNOT BE CONFIRMED. IT IS NOT KNOWN AT WHICH STAGE (DURING REMOVAL FROM DEVICE PACKAGING, DURING PREPARATION, OR DURING THE PROCEDURE) THE REPORTED DEVICE FRACTURE OR SEPARATION OCCURRED AS LIMITED INFORMATION WAS PROVIDED. IT IS MOST LIKELY THAT EXCESSIVE FORCE WAS APPLIED TO THE DEVICE AT A STAGE AFTER THE DEVICE WAS SELECTED FOR USE, RESULTING IN A BREAK IN THE DEVICE. HOWEVER, THIS CANNOT BE CONFIRMED, AND A CLEAR CONCLUSION FOR THE REPORTED EVENT CANNOT BE ESTABLISHED.
G4 PREMARKET / 510(K): K163174. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 1.20MM X 8MM EMERGE? BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 1.20MM X 8MM EMERGE? BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 379117 | EMERGE? | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC CORPORATION | H7493918908120 | 0036418373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |