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

Model Number	8577
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficulty to remove a microcatheter occurred.The 100% stenosed lesion was located in a mildly to moderately tortuous and moderately to severely calcified right coronary artery.This 150cm mamba flex microcatheter was selected for use.Upon advancement of mamba towards over a non-boston scientific guidewire to the mid and proximal chronic total occlusion (cto) lesion, the guidewire knuckled back onto itself, and the physician was able to straighten guidewire.The physician tried to advance the guidewire and mamba together, but the guidewire became frozen in the mamba catheter and was unable to advance and removed from mamba catheter.Multiple attempts were made to remove the guidewire but were unsuccessful.Then, both the guidewire and microcatheter had to be pulled and removed together as a unit.The procedure was canceled and there were no patient complications resulted in relation to this event.

• Brand Name: MAMBA FLEX
• Common Device Name: MAMBA FLEX MICROCATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17161475
• Report Number: 2124215-2023-31308
• Device Sequence Number: 12176005
• Product Code: DQY
• UDI-Device Identifier: 08714729940326
• UDI-Public: 08714729940326
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 06/20/2023

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 Expiration Date: 09/22/2024
• Device Model Number: 8577
• Device Catalogue Number: 8577
• Device Lot Number: 0030204722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASAHI INTECC MEDICAL - GAIA NEXT 3 GUIDEWIRE
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White