MAMBA? FLEX
Report
- Report Number
- 2124215-2025-63934
- Event Type
- Malfunction
- Date Received
- September 11, 2025
- Date of Event
- August 18, 2025
- Report Date
- October 20, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DQY
- UDI-DI
- 08714729940289
- PMA / PMN Number
- K171452
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G4: PREMARKET / 510(K) #: K190401. DEVICE EVALUATED BY MANUFACTURER: THE RETURNED PRODUCT CONSISTED OF THE MAMBA MICROCATHETER. VISUAL AND MICROSCOPIC INSPECTION REVEALED NO SIGNS OF DAMAGE OR IRREGULARITIES ON THE DEVICE. THE WIRE USED IN THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS, SO A .014" TEST GUIDEWIRE WAS USED FOR WIRE INSERTION TESTING. THE TEST WIRE WAS INSERTED INTO THE TIP END OF THE MAMBA AND WAS ADVANCED THROUGH THE DEVICE AND THEN REMOVED FROM THE MAMBA WITH NO RESISTANCE OR ISSUES ADVANCING OR WITHDRAWING. PRODUCT ANALYSIS DID NOT CONFIRM THE REPORTED EVENT, AS THE WIRE WAS ABLE TO BE INSERTED AND REMOVED WITHOUT RESISTANCE OR DIFFICULTIES. HOWEVER, THE CLINICAL CIRCUMSTANCES COULD NOT BE REPLICATED. INSPECTION OF THE REMAINDER OF THE DEVICE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.
G4: PREMARKET / 510(K) #: K190401.
IT REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE PATIENT WITH STABLE CORONARY ARTERY DISEASE (CAD) UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). THE TARGET LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) LOCATED IN THE CIRCUMFLEX ARTERY (CX), WHICH WAS MODERATELY TORTUOUS AND MILDLY CALCIFIED. A 135CM MAMBA FLEX MICROCATHETER WAS SELECTED FOR USE. A NON-BSC GUIDEWIRE WAS USED TO DELIVER THE MAMBA, THEN EXCHANGED FOR ANOTHER NON-BSC WIRE THAT SUCCESSFULLY CROSSED THE LESION. THE MAMBA WAS ADVANCED INTO THE DISTAL CX, AFTER WHICH THE SECOND WIRE WAS REMOVED, AND THE ORIGINAL GUIDEWIRE REINTRODUCED. DURING SUBSEQUENT REMOVAL OF THE MAMBA CATHETER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO RETRACT THE NON-BSC GUIDEWIRE. THE NON-BSC GUIDEWIRE BECAME FROZEN IN THE MAMBA CATHETER. AFTER CONSIDERABLE EFFORT, THE WIRE WAS SUCCESSFULLY REMOVED. DESPITE INCREASING RESISTANCE DURING MAMBA CATHETER REMOVAL, THE NON-BSC GUIDEWIRE WAS WIPED DOWN MULTIPLE TIMES IN AN EFFORT TO FACILITATE RETRACTION. FORTUNATELY, THE MAMBA WAS SUCCESSFULLY REMOVED WITHOUT COMPLICATION AND THE PROCEDURE SUCCESSFULLY COMPLETED WITH OTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
IT REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE PATIENT WITH STABLE CORONARY ARTERY DISEASE (CAD) UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). THE TARGET LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) LOCATED IN THE CIRCUMFLEX ARTERY (CX), WHICH WAS MODERATELY TORTUOUS AND MILDLY CALCIFIED. A 135CM MAMBA FLEX MICROCATHETER WAS SELECTED FOR USE. A NON-BSC GUIDEWIRE WAS USED TO DELIVER THE MAMBA, THEN EXCHANGED FOR ANOTHER NON-BSC WIRE THAT SUCCESSFULLY CROSSED THE LESION. THE MAMBA WAS ADVANCED INTO THE DISTAL CX, AFTER WHICH THE SECOND WIRE WAS REMOVED, AND THE ORIGINAL GUIDEWIRE REINTRODUCED. DURING SUBSEQUENT REMOVAL OF THE MAMBA CATHETER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO RETRACT THE NON-BSC GUIDEWIRE. THE NON-BSC GUIDEWIRE BECAME FROZEN IN THE MAMBA CATHETER. AFTER CONSIDERABLE EFFORT, THE WIRE WAS SUCCESSFULLY REMOVED. DESPITE INCREASING RESISTANCE DURING MAMBA CATHETER REMOVAL, THE NON-BSC GUIDEWIRE WAS WIPED DOWN MULTIPLE TIMES IN AN EFFORT TO FACILITATE RETRACTION. FORTUNATELY, THE MAMBA WAS SUCCESSFULLY REMOVED WITHOUT COMPLICATION AND THE PROCEDURE SUCCESSFULLY COMPLETED WITH OTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2330342 | MAMBA? FLEX | CATHETER, PERCUTANEOUS | DQY | BOSTON SCIENTIFIC CORPORATION | H7493928713540 | 0036290137 | 08714729940289 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |