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

Model Number 8577

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

The returned product consisted of a mamba flex 150cm microcatheter with an unknown guidewire in the device.The hub, shaft and tip were visually and microscopically examined.The device showed no damage.The reported complaint was issued for obstruction in the lumen.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.After the device was soaked, it was retested by inserting the guidewire and presented with the same restrictions.The device was returned to the water bath for an additional 7 days.The device was retested by inserting the guidewire and the guidewire transcended through the device with no restrictions, and a small piece of foreign matter (fm) exited the tip.The device was able to flush after the fm was removed.The fm was subjected to further testing which revealed that the material most closely resembled ptfe and cellulose.Ptfe is a known component within the device, and cellulose is a known component of surgical pads used during the procedure.

Event Description

Reportable based on device analysis completed on 04may2022.It was reported that when the mamba microcatheter was used, there was a problem with obstruction.However, device analysis revealed foreign material in the device lumen.

• Brand Name: MAMBA FLEX
• Type of Device: 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 ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14375868
• MDR Text Key: 291594360
• Report Number: 2134265-2022-05467
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2022

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
• Device Operator: Health Professional
• Device Model Number: 8577
• Device Catalogue Number: 8577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male