MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAMBA? FLEX; CATHETER, PERCUTANEOUS

Model Number	H7493928713540
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket / 510(k) #: k190401.
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: MAMBA? FLEX
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23027422
• Report Number: 2124215-2025-63934
• Device Sequence Number: 18520295
• Product Code: DQY
• UDI-Device Identifier: 08714729940289
• UDI-Public: (01)08714729940289(17)270412(10)36290137
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K171452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493928713540
• Device Catalogue Number: H7493928713540
• Device Lot Number: 0036290137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown