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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION MAMBA FLEX MAMBA FLEX MICROCATHETER Back to Search Results
Model Number 8577
Device Problems Device Contamination with Chemical or Other Material (2944); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/13/2020
Event Type  Malfunction  
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 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.

 
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Brand NameMAMBA FLEX
Type of DeviceMAMBA 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 Key10771583
MDR Text Key214150537
Report Number2134265-2020-14950
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK171452
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/02/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/02/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number8577
Device Catalogue Number8577
Device LOT Number0025844151
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/23/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/11/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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