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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK CORONARY; CATHETER, CORONARY, ATHERECTOMY
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CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK CORONARY; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number DBEC-125
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946); Vascular Dissection (3160)
Event Date 03/01/2017
Event Type  Death  
Event Description
Patient admitted to cardiac cath lab for a possible percutaneous coronary intervention (pci).The procedure progressed to a need for a cardiovascular systems incorporated (csi) rotablation for a lad vessel lesion.The csi viperwire advanced wire system was implemented several times.When drawing back, the diamond head lacerated the lad.The patient's blood pressure dropped requiring cpr.Cardiac surgery was consulted and the patient was taken to the o.R.Emergently.Patient expired.
 
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Brand Name
DIAMONDBACK CORONARY
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS INCORPORATED
14740 kirby dr.
houston TX 77047
MDR Report Key6435379
MDR Text Key70880224
Report Number6435379
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Physician
Device Model NumberDBEC-125
Device Catalogue NumberDBEC-125
Device Lot Number177524
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/20/2017
Event Location Hospital
Date Report to Manufacturer03/20/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Outcome(s) Death;
Patient Age86 YR
Patient Weight54
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