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

Model Number	8577
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a separation had occurred.While a procedure was in progress, the tip of the 135cm mamba flex catheter separated from the rest of the device.All components of the device remained on the wire, and the physician was able to remove everything from the patient anatomy.It was noted that the vessel was severely calcified and thought to have caused the issue.
Additional Manufacturer Narrative
Device returned to manufacturer: the hub, shaft and tip were microscopically examined.The guidewire was removed from the device by pulling it from the tip end.The device showed no shaft damage; however, tip damage was noticed.It was noticed that the guidewire tip coils showed severe damage at the tip area.The tip of the mamba showed deformation damage; however, the tip was not detached.No other issues were identified during the product analysis.Inspection of the remainder of the device, revealed no damage or irregularities.The complaint was not confirmed for a detachment; however, tip damage was confirmed.
Event or Problem Description
It was reported a separation had occurred.While a procedure was in progress, the tip of the 135cm mamba flex catheter separated from the rest of the device.All components of the device remained on the wire, and the physician was able to remove everything from the patient anatomy.It was noted that the vessel was severely calcified and thought to have caused the issue.

• Brand Name: MAMBA FLEX
• Common Device Name: MAMBA FLEX MICROCATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11419052
• Report Number: 2134265-2021-02735
• Device Sequence Number: 16838204
• Product Code: DQY
• UDI-Device Identifier: 08714729940289
• UDI-Public: 08714729940289
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 09/11/2022
• Device Model Number: 8577
• Device Catalogue Number: 8577
• Device Lot Number: 0026001185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 04/07/2021
• Patient Sequence Number: 1