MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAMBA FLEX; MAMBA FLEX MICROCATHETER

Model Number	8577
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that difficulty to remove a microcatheter occurred.A percutaneous coronary intervention (pci) of a chronic total occluded artery was performed on a patient with coronary artery disease (cad).The target lesion was located in the 100% stenosed severely calcified bifurcated left main (lm) artery and bifurcated obtuse margin (om) artery.A 150 cm mamba flex microcatheter was advanced to the calcified lesion, distal to the chronic total occlusion (cto), but difficulties removing the device occurred.The device was unable to pull back.Another wire and balloon were inserted beside the microcatheter, and the balloon was inflated several times.The mamba then became unstuck, and was removed intact.The procedure was completed with other stents, which were post dilated.There were no further issues, and no patient complications resulted in relation to this event.
Event or Problem Description
It was reported that difficulty to remove a microcatheter occurred.A percutaneous coronary intervention (pci) of a chronic total occluded artery was performed on a patient with coronary artery disease (cad).The target lesion was located in the 100% stenosed severely calcified bifurcated left main (lm) artery and bifurcated obtuse margin (om) artery.A 150 cm mamba flex microcatheter was advanced to the calcified lesion, distal to the chronic total occlusion (cto), but difficulties removing the device occurred.The device was unable to pull back.Another wire and balloon were inserted beside the microcatheter, and the balloon was inflated several times.The mamba then became unstuck, and was removed intact.The procedure was completed with other stents, which were post dilated.There were no further issues, and no patient complications resulted in relation to this event.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a mamba flex 150cm microcatheter with blood in the hub.The device was visually and microscopically examined.Inspection of the hub, shaft and tip revealed a kink in the shaft 2.5cm proximal of the tip.There was no other damage or defect observed.

• Brand Name: MAMBA FLEX
• Common Device Name: MAMBA FLEX MICROCATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road cork; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14360667
• Report Number: 2134265-2022-05374
• Device Sequence Number: 4077684
• Product Code: DQY
• UDI-Device Identifier: 08714729940326
• UDI-Public: 08714729940326
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2023
• Device Model Number: 8577
• Device Catalogue Number: 8577
• Device Lot Number: 0027535748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Race: Black Or African American