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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAMBA MAMBA MICROCATHETER

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BOSTON SCIENTIFIC CORPORATION MAMBA MAMBA MICROCATHETER Back to Search Results
Model Number 8577
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Perforation of Vessels (2135)
Event Date 11/02/2020
Event Type  Death  
Event Description

It was reported that a death occurred. A percutaneous coronary intervention was being performed on a chronic totally occluded lesion in the left main and left anterior descending (lad) coronary artery. A number of products were used during the case including two mamba flex microcatheters, a 20mm x 4. 50mm nc quantum apex balloon, a fighter, hornet and judo guidewires, a 2. 00mm x 40mm apex balloon, a 20mm x 4. 00mm nc quantum apex balloon, a guidezilla ii guide extension catheter, and an opticross imaging catheter. After what seemed to be a successful "investment" procedure, the physician took final shots to confirm there were no perforations or dissections visible, and none were confirmed. An echocardiogram was performed as a precautionary measure and determined there was a minor perfusion around the pericardium. The patient was a previous bypass patient and therefore his pericardium was no longer intact. It was noticed there was a perforation at what seemed to be the anastomosis site of the lima to the lad. A non-boston scientific stent was placed. After the stent was placed it was determined there was still a perforation, so a balloon was inflated for 20 minutes in an attempt to prevent tamponade. After this was unsuccessful, another non-boston scientific stent was placed. The bleeding had not yet stopped. Another non-boston scientific stent was placed with no ability to stop the perfusion. The patient began to crash and a pericardiocentesis was completed. After many attempts at trying to get the patient back and to stop the bleeding, coils were delivered as well as thrombin injected. The patient was shocked and given chest compressions until he was finally pronounced dead.

 
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Brand NameMAMBA
Type of DeviceMAMBA MICROCATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10876227
MDR Text Key217372023
Report Number2134265-2020-15659
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 11/20/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number8577
Device Catalogue Number8577
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/02/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/20/2020 Patient Sequence Number: 1
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