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

Model Number	8577
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the catheter was difficult to remove and froze on the guidewire.An atherectomy procedure was being performed on a 90% stenosed, severely calcified and mildly tortuous lesion in the mid left anterior descending coronary artery.A mamba flex microcatheter was being advanced over a non-boston scientific guidewire and could not be advanced any further or be removed.It became stuck on the guidewire and both the guidewire and microcatheter had to be removed together as a unit.The procedure was successfully completed with a different device without issue or patient injury.The patient was stable post procedure.
Event or Problem Description
It was reported the catheter was difficult to remove and froze on the guidewire.An atherectomy procedure was being performed on a 90% stenosed, severely calcified and mildly tortuous lesion in the mid left anterior descending coronary artery.A mamba flex microcatheter was being advanced over a non-boston scientific guidewire and could not be advanced any further or be removed.It became stuck on the guidewire and both the guidewire and microcatheter had to be removed together as a unit.The procedure was successfully completed with a different device without issue or patient injury.The patient was stable post procedure.
Additional Manufacturer Narrative
Device returned to manufacturer: returned product consisted of a mamba flex 135 microcatheter.No guidewire was returned in the device or with the device.The hub, shaft and tip were microscopically examined.The device showed no shaft damage.The reported complaint was issued for a guidewire restriction/stuck during the procedure.The devices guidewire lumen was hydrated with fluid.It was noticed that the device showed blood being expelled from the lumen with some difficulty.A.014 test guidewire was hydrated and inserted into the hub end of the device and transcended through the device with a slight restriction due to the blood and possible dried saline and contrast.The guidewire did transcend through the device after the device was flushed.Per the returned information a.009 rota wire was used as an exchange wire for the rota procedure.During analysis a.009 test rota wire was used to insert into the guidewire lumen.The rota wire transcended through the device with no hesitation or restriction.The devices shaft, at the distal end was curved into a simulated tortuous anatomy and the guide wire showed a slight restriction; however, the guidewire moved freely through the device.No other issues were identified during the product analysis.The complaint was confirmed for a restriction/friction of the guidewire due to the dried blood and possibly saline/contrast in the guidewire lumen.

• 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: 11272179
• Report Number: 2134265-2021-01103
• Device Sequence Number: 4188648
• Product Code: DQY
• UDI-Device Identifier: 08714729940289
• UDI-Public: 08714729940289
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 03/19/2021

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: 11/02/2022
• Device Model Number: 8577
• Device Catalogue Number: 8577
• Device Lot Number: 0026287762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/19/2021
• Patient Sequence Number: 1
• Patient Age: 78 YR