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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 Entrapment of Device (1212); Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2021
Event Type  malfunction  
Event Description
It was reported that the device was stuck to the guidewire.During a coronary angiogram and percutaneous coronary intervention, they decided to use a mamba microcatheter.They inserted a guidewire into the mamba and planned to remove the mamba with the aim of keeping the wire in place.After they found a suitable place for the guidewire they started to remove the mamba and found that it had pulled the wire out from its position.The physician mentioned that it felt as though the mamba was stuck to the wire.The procedure was able to be completed with no patient injury.
 
Manufacturer Narrative
Device returned to manufacturer: a mamba flex 135 microcatheter with a.014 guidewire stuck in the device was returned for device analysis.The hub, shaft and tip were microscopically examined.The device showed no shaft.The reported complaint was issued for a guidewire sticking during the procedure.The device return with a guidewire protruding from the tip approximately 86.5cm.The guidewire was checked for the correct size which was.014 which is compatible with this mamba device.The guidewire that was stuck was attempted to be removed from the device.The guidewire could not be removed.The catheter was soaked for a period of 48 hours in a 37c water bath to try and loosen the guidewire and remove it from the lumen.The wire still could not be removed.No other issues were identified during the product analysis.The complaint was confirmed for a stuck guidewire in the catheter.
 
Event Description
It was reported that the device was stuck to the guidewire.During a coronary angiogram and percutaneous coronary intervention, they decided to use a mamba microcatheter.They inserted a guidewire into the mamba and planned to remove the mamba with the aim of keeping the wire in place.After they found a suitable place for the guidewire they started to remove the mamba and found that it had pulled the wire out from its position.The physician mentioned that it felt as though the mamba was stuck to the wire.The procedure was able to be completed with no patient injury.
 
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Brand Name
MAMBA FLEX
Type of Device
MAMBA FLEX MICROCATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11636559
MDR Text Key244636748
Report Number2134265-2021-04439
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/11/2023
Device Model Number8577
Device Catalogue Number8577
Device Lot Number0026614596
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2021
Date Manufacturer Received05/14/2021
Patient Sequence Number1
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