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

Model Number	8577
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned to boston scientific for analysis.Returned product consisted of a mamba flex microcatheter.The hub, shaft and tip were microscopically examined.The device showed a damaged area approximately 65.5cm from the tip.The foreign material the customer returned was confirmed.The returned rota wire was inserted into the lumen of the device.The wire transcended through the device until it met resistance approximately 115cm from the hub.The device was x-rayed; however, nothing appeared on the x-ray image.The wire was removed, and the device was soaked for a period of 24 hours until the lumen blockage was cleared.A syringe of fluid was injected through the device to show patency.It was noticed that the damaged area inflated like a balloon which gives the indication of shaft damage and ptfe inner liner damage.The wire was reinserted and transcended through the device with a slight sticking point at the 65.5cm damage.The foreign material that was recovered was tested on the ftir testing equipment.The foreign material that was noticed is consistent with the wire interfering with the ptfe liner.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.No other issues were identified during the product analysis.The complaint was confirmed for difficulty loading the wire and foreign material.
Event or Problem Description
It was reported that foreign material was present in the device.A percutaneous coronary intervention was being performed to treat a blockage in the ostial right coronary artery.A rota wire was being used and would not advance through the mamba flex microcatheter.The catheter was removed and flushed and a hair-like substance came out.The mamba device was not reinserted in the body.The rota wire was used to complete the procedure.No patient complications were reported.

• 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: 10771583
• Report Number: 2134265-2020-14950
• Device Sequence Number: 19868823
• Product Code: DQY
• UDI-Device Identifier: 08714729940289
• UDI-Public: 08714729940289
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2020

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: 08/11/2022
• Device Model Number: 8577
• Device Catalogue Number: 8577
• Device Lot Number: 0025844151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR