NEPHROMAX
Report
- Report Number
- 3005099803-2021-06191
- Event Type
- Malfunction
- Date Received
- December 2, 2021
- Date of Event
- November 9, 2021
- Report Date
- January 11, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LJE
- UDI-DI
- 08714729012641
- PMA / PMN Number
- K121614
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. SHOULD THE DEVICE BECOME AVAILABLE FOR ANALYSIS AND THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
BLOCK H6: MEDICAL DEVICE CODE A0414 CAPTURES THE REPORTABLE EVENT OF BALLOON TORN. BLOCK H10: INVESTIGATION RESULT A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE BALLOON WAS TORN LONGITUDINALLY FROM DISTAL OF THE DISTAL MARKER BAND EXTENDING ACROSS THE PROXIMAL FROM THE DISTAL MARKER BAND, THEREBY CONFIRMING THE REPORTED EVENT. A VISUAL AND TACTILE EXAMINATIONS REVEALED THAT THERE WAS NO PROBLEM FOUND TO THE TIP AND THE SHAFT OF THE DEVICE. ADDITIONALLY, NO PROBLEM WAS OBSERVED ON THE MARKERBANDS. THIS FAILURE IS LIKELY DUE TO FACTORS ENCOUNTERED DURING THE PROCEDURE, SUCH AS DIFFICULT PATIENT ANATOMY AND INTERACTION WITH THE DEVICE AND A STONE WHEN THE DEVICE WAS BEING POSITIONED, CAUSING WEAKNESS IN THE BALLOON MATERIAL, LEADING TO THE BALLOON BURSTING AND LONGITUDINAL TEAR IN THE BALLOON MATERIAL. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PATIENT CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTRIPSY (PNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS TORN AND WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE PHOTOS SUBMITTED BY THE CUSTOMER CONFIRMED THE TORN ON THE DISTAL SECTION OF THE BALLOON MATERIAL.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTRIPSY (PNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS TORN AND WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE PHOTOS SUBMITTED BY THE CUSTOMER CONFIRMED THE TORN ON THE DISTAL SECTION OF THE BALLOON MATERIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1815239 | NEPHROMAX | CATHETER, NEPHROSTOMY | LJE | BOSTON SCIENTIFIC CORPORATION | M0062101170 | 0026784500 | 08714729012641 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |