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

Model Number	8577
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It reported that removal difficulties occurred.A percutaneous coronary intervention was being performed.The target lesion was located in the 99% stenosed severely calcified and mildly tortuous left anterior descending artery.This 135cm mamba flex microcatheter along with a rotawire guidewire were selected.During the procedure the mamba microcatheter became sticky and was very difficult to remove from the rotawire.They attempted to flush the lumen which was also difficult, they remove the device from the patient by firmly pulling the mamba off of the rotawire.During the removal the rotawire guidewire became severely mangled.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It reported that removal difficulties occurred.A percutaneous coronary intervention was being performed.The target lesion was located in the 99% stenosed severely calcified and mildly tortuous left anterior descending artery.This 135cm mamba flex microcatheter along with a rotawire guidewire were selected.During the procedure the mamba microcatheter became sticky and was very difficult to remove from the rotawire.They attempted to flush the lumen which was also difficult, they remove the device from the patient by firmly pulling the mamba off of the rotawire.During the removal the rotawire guidewire became severely mangled.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the carrier hoop was flushed prior to mamba being removed from the hoop.The inner lumen was flushed prior to use in the patient or guidewire insertion.An antegrade approach was performed.The target lesion was located in a 99% stenosed, moderately tortuous, severely calcified, proximal artery.Lesion difficulty occurred in a, b1, b2, c - c.The guidewire that was used during this procedure had a 1mm bend from distal tip, and was a fresh guidewire (less than 15 minutes in the patient).The friction with the guidewire occurred in the mid shaft of the mamba.After the resistance was encountered, the mamba catheter was flushed, which made an improvement.A new guidewire was also used, which did and did not improve the resistance.No further patient complications were reported in relation to this event.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a mamba flex 135cm microcatheter with no guidewire in the device, and blood in the hub and lumen.The hub, shaft and tip were visually and microscopically examined.The device showed no shaft damage.The reported complaint was issued for difficult to remove the guidewire during the procedure.No guidewire was returned.A.014 test guidewire was inserted into the hub end of the device and the wire transcended through the device with no hesitations or restrictions through the lumen and exited the tip end.The device was flushed with a syringe of fluid, and the fluid as well as blood exited the tip end.The tip was damaged as part of it was bent outward and misshapen.Inspection of the remainder of the device revealed no other damage or defects.Product analysis could not confirm the reported events, as the guidewire passed through with no issues or resistance, was able to flush, and clinical circumstances could not be replicated.

• 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: 13830516
• Report Number: 2134265-2022-03149
• Device Sequence Number: 16530532
• Product Code: DQY
• UDI-Device Identifier: 08714729940289
• UDI-Public: 08714729940289
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

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: 08/17/2023
• Device Model Number: 8577
• Device Catalogue Number: 8577
• Device Lot Number: 0027854403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 03/20/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown