ESCAPE
Report
- Report Number
- 2124215-2024-47939
- Event Type
- Malfunction
- Date Received
- August 7, 2024
- Date of Event
- June 20, 2024
- Report Date
- October 3, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FFL
- UDI-DI
- 08714729121299
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF BASKET WIRE BREAK. BLOCK H11: INVESTIGATION RESULTS, THE RETURNED ESCAPE BASKET WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE DEVICE RETURNED WITH THE BASKET ON ITS CLOSE POSITION AND THE HANDLE WAS IN GOOD CONDITION. THE BLACK HEAT SHRINK OF THE BASKET WAS BENT/KINKED. MICROSCOPIC EXAMINATION IDENTIFIED THAT THE SHEATH WAS TORN AND DETACHED IN THE CENTER. ADDITIONALLY, THE SHEATH WAS FOUND BENT/KINKED AT THE DISTAL SECTION. THERE WAS NO EVIDENCE OF BASKET WIRE BREAK. FUNCTIONAL EXAMINATION WAS PERFORMED, AND THE HANDLE WAS ACTUATED; HOWEVER, THE BASKET WAS UNABLE TO OPEN AND CLOSE DUE TO THE DETACHMENT. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT OF BASKET WIRE BREAK WAS NOT CONFIRMED. HOWEVER, IT WAS FOUND THAT THE BASKET HAD THE BLACK HEAT SHRINK BENT/KINKED. ALSO, THE SHEATH WAS TORN, DETACHED IN THE CENTER, AND IT WAS BENT/KINKED AT THE DISTAL SECTION. THESE COULD BE RELATED TO HANDLING AND MANIPULATION OF THE DEVICE DURING PREPARATION. IT IS PROBABLE THAT AN EXCESS OF FORCE APPLIED TO THE DEVICE SUCH AS OPERATIONAL FACTORS COULD CAUSE ALL THESE DAMAGES OBSERVED. BASED ON THE ANALYSIS RESULTS, AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE WAS ASSIGNED TO THIS INVESTIGATION.
BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF BASKET WIRE BREAK. BLOCK H11: INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, THE REPORTED BASKET WIRE DETACHMENT COULD NOT BE CONFIRMED. HOWEVER, A MEDIA ANALYSIS WAS PERFORMED ON THE PICTURE SUBMITTED BY THE CUSTOMER, AND IT WAS FOUND THAT THE SHEATH OF AN ESCAPE BASKET WAS DETACHED/SEPARATED. ADDITIONALLY, THE CONDITION OF THE BASKET COULD NOT BE APPRECIATED ON THE PICTURE PROVIDED. BASED ON THE AVAILABLE INFORMATION IT IS POSSIBLE THAT THE OBSERVED SHEATH DETACHMENT COULD BE RELATED TO HANDLING AND MANIPULATION OF THE DEVICE; IT IS PROBABLE THAT AN EXCESS OF FORCE APPLIED TO THE DEVICE SUCH AS OPERATIONAL FACTORS DURING USE COULD CAUSE THE OBSERVED SHEATH DETACHMENT. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE CANNOT BE ESTABLISHED DUE TO LACK OF EVIDENCE. ADDITIONALLY, WITHOUT A PROPER EVALUATION OF THE DEVICE, IT REMAINS UNKNOWN THE MOST PROBABLE CAUSES THAT COULD HAVE CONTRIBUTED TO THE EVENT. THEREFORE, A CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION.
IT WAS REPORTED THAT AN ESCAPE BASKET DEVICE WAS USED DURING AN ENDOSCOPIC URETEROPLASTY PROCEDURE. DURING PREPARATION, THE BASKET WIRE COMPLETELY DETACHED FROM THE BASKET OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
IT WAS REPORTED THAT AN ESCAPE BASKET DEVICE WAS USED DURING AN ENDOSCOPIC URETEROPLASTY PROCEDURE. DURING PREPARATION, THE BASKET WIRE COMPLETELY DETACHED FROM THE BASKET OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 262859 | ESCAPE | DISLODGER, STONE, BASKET, URETERAL, METAL | FFL | BOSTON SCIENTIFIC CORPORATION | M0063902010 | 0033572655 | 08714729121299 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |