PULSE
Report
- Report Number
- 2124215-2025-35369
- Event Type
- Death
- Date Received
- June 4, 2025
- Date of Event
- January 16, 2025
- Report Date
- September 15, 2025
- Manufacturer
- LUMENIS LTD
- Product Code
- GEX
- PMA / PMN Number
- K170121
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DATE OF DEATH (B2) WAS APPROXIMATED BASED ON AN ESTIMATED EARLIEST PROCEDURE DATE NOTED IN THE STUDY AND OTHER INFORMATION PROVIDED REGARDING THE DEATH EVENT. KLEIN, C., ANRACT, J., PINAR, U., LACROIX, X., MANSOUR, R., ROBERT, G., DELONGCHAMPS, N.B. (2025). "COMPARATIVE STUDY OF HOLEP IN ELDERLY PATIENTS WITH INDWELLING CATHETERS: A RETROSPECTIVE DUAL-CENTER STUDY". WORLD JOURNAL OF UROLOGY 43, 75. HTTPS://DOI.ORG/10.1007/S00345-024-05437-9 DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
ADDITIONAL INFORMATION PROVIDED BY THE PHYSICIAN CONFIRMED THE PATIENT'S DEATH DESCRIBE IN THE LITERATURE WAS NOT RELATED TO THE HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE OR A MALFUNCTION OF THE DEVICE. BOSTON SCIENTIFIC DOES NOT HAVE REPORTING RESPONSIBILITY IF A QUALIFIED HEALTH CARE PROFESSIONAL HAD REASONABLE INFORMATION TO MAKE THE MEDICAL JUDGMENT THAT THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO DEATH AND THE PRODUCT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH IN RECURRENCE. THEREFORE, THE MANUFACTURER HAS DETERMINED THIS EVENT NO LONGER MEETS REPORTING CRITERIA FOR THE REPORTED DEATH. KLEIN, C., ANRACT, J., PINAR, U., LACROIX, X., MANSOUR, R., ROBERT, G., DELONGCHAMPS, N.B. (2025). "COMPARATIVE STUDY OF HOLEP IN ELDERLY PATIENTS WITH INDWELLING CATHETERS: A RETROSPECTIVE DUAL-CENTER STUDY". WORLD JOURNAL OF UROLOGY 43, 75. HTTPS://DOI.ORG/10.1007/S00345-024-05437-9. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE WORLD JOURNAL OF UROLOGY THAT A COMPARATIVE RETROSPECTIVE ANALYSIS WAS CONDUCTED TO EVALUATE THE SAFETY AND EFFICACY OF HOLEP IN PATIENTS AGED OVER 85 YEARS WITH INDWELLING CATHETER (IDC). A OF A TOTAL OF 144 PATIENTS, WITH 71 IN THE GROUP OF PATIENTS AGED 85 OR GREATER AND 73 IN THE CONTROL GROUP WITH PATIENTS UNDER 70 YEARS OF AGE, WERE EVALUATED FOR RATE OF POSTOPERATIVE SPONTANEOUS MICTURITION, WITH SUCCESS DEFINED AS THE ABILITY TO RESUME SATISFACTORY SPONTANEOUS VOIDING WITHOUT SIGNIFICANT POST-VOID RESIDUAL VOLUME. MEDICAL FILES OF PATIENTS OPERATED BETWEEN JUNE 2012 AND APRIL 2020, AT TWO ACADEMIC CENTERS IN FRANCE, WERE REVIEWED TO RETRIEVE THOSE WITH HISTORY OF ACUTE OR CHRONIC URINARY RETENTION AND TRIAL WITHOUT CATHETER (TWOC) FAILURE REQUIRING MAINTENANCE OF IDC AT THE TIME OF SURGERY. FOLLOW-UP ASSESSMENTS WERE CONDUCTED AT BASELINE OF 3 MONTHS, 6 MONTHS, AND 12 MONTHS. FOLLOWING THE PROCEDURES, THE FOLLOWING COMPLICATIONS WERE REPORTED FOR THE OLDER PATIENTS GROUP: 8 PATIENTS REQUIRED BLOOD TRANSFUSIONS, 17 PATIENTS HAD TWOC FAILURE DURING HOSPITALIZATION, AT 3-MONTHS EVALUATION 5 PATIENTS COULD NOT VOID SPONTANEOUSLY, AND AT 12-MONTHS EVALUATION 2 PATIENTS REMAINED WITH AN IDC, 8 PATIENTS HAD URINARY INCONTINENCE, AND 10 PATIENTS HAD DIED. FOLLOWING THE PROCEDURES, THE FOLLOWING COMPLICATIONS WERE REPORTED FOR THE YOUNGER PATIENTS GROUP: 7 PATIENTS REQUIRED BLOOD TRANSFUSIONS, 7 PATIENTS HAD TWOC FAILURE DURING HOSPITALIZATION, AND AT 12-MONTHS EVALUATION 4 PATIENTS HAD URINARY INCONTINENCE AND 2 PATIENTS HAD DIED. IT WAS NOTED THAT ONLY ONE DEATH WAS DIRECTLY RELATED TO SURGERY (SEVERE SEPSIS DUE TO PNEUMONIA, COMPLICATED BY MULTIORGAN FAILURE, LEADING TO DEATH ON POSTOPERATIVE DAY 7). THIS REPORT IS FOR THE DEATH DIRECTLY RELATED TO SURGERY REPORTED IN THE ARTICLE. REFERENCE LITERATURE ARTICLE "COMPARATIVE STUDY OF HOLEP IN ELDERLY PATIENTS WITH INDWELLING CATHETERS: A RETROSPECTIVE DUAL-CENTER STUDY" INCLUDED WITH THIS REPORT FOR A FULL LISTING OF PHYSICIANS AND HEALTH CARE FACILITIES.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE WORLD JOURNAL OF UROLOGY THAT A COMPARATIVE RETROSPECTIVE ANALYSIS WAS CONDUCTED TO EVALUATE THE SAFETY AND EFFICACY OF HOLMIUM LASER ENUCLEATION OF THE PROSTAE (HOLEP) IN PATIENTS AGED OVER 85 YEARS WITH INDWELLING CATHETER (IDC). A OF A TOTAL OF 144 PATIENTS, WITH 71 IN THE GROUP OF PATIENTS AGED 85 OR GREATER AND 73 IN THE CONTROL GROUP WITH PATIENTS UNDER 70 YEARS OF AGE, WERE EVALUATED FOR RATE OF POSTOPERATIVE SPONTANEOUS MICTURITION, WITH SUCCESS DEFINED AS THE ABILITY TO RESUME SATISFACTORY SPONTANEOUS VOIDING WITHOUT SIGNIFICANT POST-VOID RESIDUAL VOLUME. HOLEP WAS PERFORMED USING A 100 W HOLMIUM YAG LASER GENERATOR, A 26FR RESECTOSCOPE, AND A DRILLCUT MORCELLATOR (KARL STORZ COMPANY). MEDICAL FILES OF PATIENTS OPERATED BETWEEN JUNE 2012 AND APRIL 2020, AT TWO ACADEMIC CENTERS IN FRANCE, WERE REVIEWED TO RETRIEVE THOSE WITH HISTORY OF ACUTE OR CHRONIC URINARY RETENTION AND TRIAL WITHOUT CATHETER (TWOC) FAILURE REQUIRING MAINTENANCE OF IDC AT THE TIME OF SURGERY. FOLLOW-UP ASSESSMENTS WERE CONDUCTED AT BASELINE OF 3 MONTHS, 6 MONTHS, AND 12 MONTHS. THE FOLLOWING INTRA-OPERATIVE COMPLICATIONS WERE REPORTED FOR THE OLDER PATIENTS GROUP: 3 PATIENTS HAD CAPSULAR PERFORATIONS DURING PROCEDURE, AND 2 PROCEDURES WERE CONVERTED TO TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) DUE TO LASER FAILURE. FOLLOWING THE PROCEDURES, THE FOLLOWING COMPLICATIONS WERE REPORTED: 8 PATIENTS REQUIRED BLOOD TRANSFUSIONS AND 17 PATIENTS HAD TWOC FAILURE DURING HOSPITALIZATION. AT 3-MONTHS EVALUATION 5 PATIENTS COULD NOT VOID SPONTANEOUSLY, AND AT 12-MONTHS EVALUATION 2 PATIENTS REMAINED WITH AN IDC, 8 PATIENTS HAD URINARY INCONTINENCE, AND 10 PATIENTS HAD DIED. THE FOLLOWING INTRA-OPERATIVE COMPLICATIONS WERE REPORTED FOR THE YOUNGER PATIENTS GROUP: 3 PATIENTS HAD CAPSULAR PERFORATIONS AND 4 PATIENTS HAD BLADDER PERFORATIONS DURING PROCEDURE. FOLLOWING THE PROCEDURES, THE FOLLOWING COMPLICATIONS WERE REPORTED: 7 PATIENTS REQUIRED BLOOD TRANSFUSIONS AND 7 PATIENTS HAD TWOC FAILURE DURING HOSPITALIZATION. AT 12-MONTHS EVALUATION 4 PATIENTS HAD URINARY INCONTINENCE AND 2 PATIENTS HAD DIED. IT WAS NOTED THAT ONLY ONE DEATH WAS DIRECTLY RELATED TO SURGERY (SEVERE SEPSIS DUE TO PNEUMONIA, COMPLICATED BY MULTIORGAN FAILURE, LEADING TO DEATH ON POSTOPERATIVE DAY 7). THIS REPORT IS FOR THE DEATH DIRECTLY RELATED TO SURGERY REPORTED IN THE ARTICLE. ADDITIONAL INFORMATION IT WAS FURTHER REPORTED THAT THE PATIENT WAS OPERATE WITH THE LUMENIS DEVICE, THE PATIENT HAD SEVERAL COMORBITIES AND LONG MEDICAL HISTORY OF CARDIOVASCULAR DISEASE. THE PATIENT DEVELOPED A POST-OPERATIVE INFECTIOUS COMPLICATION THAT COULD HAVE OCCURRED AT HOME OR DURING ANOTHER HOSPITALIZATION. THE PHYSICIAN STATED THAT FROM THE MEDICAL STANDPOINT, NO MALFUNCTION OF THE PRODUCT OR THE HOLEP PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 362227 | PULSE | POWERED LASER SURGICAL INSTRUMENT | GEX | LUMENIS LTD | UNK-P-P100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Death |