HURRICANE RX
Report
- Report Number
- 3005099803-2022-07597
- Event Type
- Malfunction
- Date Received
- December 22, 2022
- Date of Event
- December 2, 2022
- Report Date
- March 8, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729283812
- PMA / PMN Number
- K001338
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF RX TUNNEL DETACHED.
BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF RX TUNNEL DETACHED. BLOCK H10: INVESTIGATION RESULTS: THE RETURNED HURRICANE RX DILATATION BALLOON WAS ANALYZED AND A VISUAL EXAMINATION OF THE CATHETER FOUND THE RX SLEEVE WAS DETACHED. NO DAMAGES WERE FOUND TO THE BALLOON. MICROSCOPIC INSPECTION OF THE CATHETER CONFIRMED THE RX SLEEVE WAS DETACHED. FUNCTIONAL ANALYSIS WAS PERFORMED AND THE BALLOON WAS INFLATED WITHOUT A PROBLEM AND HELD PRESSURE. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT RX TUNNEL DETACHED WAS CONFIRMED AS THE RX SLEEVE WAS DETACHED ON THE RETURNED DEVICE. IT IS POSSIBLE THAT FACTORS ENCOUNTERED DURING THE PROCEDURE SUCH AS THE INTERACTION OF THE DEVICE WITH THE SCOPE WHILE THE CATHETER IS ADVANCED COULD CAUSE THE RX SLEEVE TO DETACH. THESE FACTORS AND INTERACTIONS COULD INFLUENCE THE DAMAGE FOUND IN THE RETURNED DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL.
THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4).
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BLACK SHEATH DETACHED INTO THE SCOPE. THE CUSTOMER STATED THAT NOTHING DETACHED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BLACK SHEATH DETACHED INTO THE SCOPE. THE CUSTOMER STATED THAT NOTHING DETACHED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BLACK SHEATH DETACHED INTO THE SCOPE. THE CUSTOMER STATED THAT NOTHING DETACHED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2826695 | HURRICANE RX | CATHETER, BILIARY, DIAGNOSTIC | FGE | BOSTON SCIENTIFIC CORPORATION | M00545900 | 0030276523 | 08714729283812 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |