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

Model Number	8577
Medical Device Problem Codes	Difficult to Flush (1251); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It reported that removal difficulties occurred.The 70% stenosed target lesion was none tortuous and moderately calcified left anterior descending coronary artery (lad).A 135 cm mamba flex was used as an exchange device during a rotablation procedure.The mamba was flushed, and the non-boston scientific (bsc) wire was inserted into the catheter.The mamba and non-bsc wire devices placed into the guide catheter at the same time and advanced to the lesion with the non-bs wire leading across the calcified lesion.Then, the non-bsc wire was removed, and the rotowire drive was advanced in lesion.Once the rotowire drive was at distal to the lesion, the mamba was removed.The rotablation successfully completed and the rotapro was removed over the rotawire.Then, the mamba advanced into the distal lad over the rotawire.Upon removal, the rotawire was difficult to remove from the mamba.The physician removed both the mamba catheter and rotawire together.Then, the rotawire removed from the mamba outside the patient, and tried to flush the mamba but could not flush it.The mamba catheter was able to flush it with a non-boston scientific syringe.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned device consisted of a mamba microcatheter.A non-boston scientific (bsc) wire and non-bsc syringe were returned.Visual inspection and microscopic examination of the device revealed no damage or defect.A.014 test guidewire was inserted into the tip end of the device and the wire transcended through the device without hesitations or restrictions in the lumen.A syringe with fluid was attached to the hub and the device was flushed without issue.Product analysis could not confirm the reported event as clinical circumstances could not be replicated, and there was no damage to the returned device.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It reported that removal difficulties occurred.The 70% stenosed target lesion was none tortuous and moderately calcified left anterior descending coronary artery (lad).A 135 cm mamba flex was used as an exchange device during a rotablation procedure.The mamba was flushed, and the non-boston scientific (bsc) wire was inserted into the catheter.The mamba and non-bsc wire devices placed into the guide catheter at the same time and advanced to the lesion with the non-bs wire leading across the calcified lesion.Then, the non-bsc wire was removed, and the rotowire drive was advanced in lesion.Once the rotowire drive was at distal to the lesion, the mamba was removed.The rotablation successfully completed and the rotapro was removed over the rotawire.Then, the mamba advanced into the distal lad over the rotawire.Upon removal, the rotawire was difficult to remove from the mamba.The physician removed both the mamba catheter and rotawire together.Then, the rotawire removed from the mamba outside the patient, and tried to flush the mamba but could not flush it.The mamba catheter was able to flush it with a non-boston scientific syringe.There were no patient complications reported.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18852286
• Report Number: 2124215-2024-13901
• Device Sequence Number: 12633970
• Product Code: DQY
• UDI-Device Identifier: 08714729940289
• UDI-Public: 08714729940289
• 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): 04/16/2024

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: 10/18/2025
• Device Model Number: 8577
• Device Catalogue Number: 8577
• Device Lot Number: 0032677326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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