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

Model Number	8577
Medical Device Problem Codes	Difficult to Flush (1251); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.Device evaluated by manufacturer: returned product consisted of a mamba flex 135cm microcatheter there was no guidewire returned.The hub, shaft and tip were visually and microscopically examined.The device showed no damage.The device was flushed with a syringe of fluid and the fluid did not come out of the tip end.A.014 test guidewire was inserted into the hub end of the device and the wire transcended through the device with hesitations and restrictions in the lumen.The wire never reached the full length of the catheter due to the restrictions.The device was soaked in a bath.The device was retested by inserting the guidewire and the guidewire transcended through the device with no restrictions, and a small piece of fm exited the tip.The device was able to flush after the foreign material (fm) was removed.The identify the fm was a 95% cotton and 5% lycra.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022 it was reported that a guidewire could not advance through the device.A mamba infusion catheter was selected for use.During preparation a guidewire failed to load through the mamba.The mamba was replaced with another mamba and the procedure was completed.No patient complications were reported.However, device analysis revealed foreign material within the mamba.

• 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 ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15279041
• Report Number: 2124215-2022-31912
• Device Sequence Number: 20588261
• Product Code: DQY
• UDI-Device Identifier: 08714729940289
• UDI-Public: 08714729940289
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/23/2022

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: 11/17/2023
• Device Model Number: 8577
• Device Catalogue Number: 8577
• Device Lot Number: 0028400920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown