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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. SPRINTER®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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MEDTRONIC, INC. SPRINTER®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number SPR1512W
Device Problems Break (1069); Material Rupture (1546)
Patient Problem Calcium Deposits/Calcification (1758)
Event Date 01/09/2018
Event Type  malfunction  
Event Description
Dr ordered the balloons to be inflated in the patient's right coronary artery which had been previously stented and was heavily calcified.The balloons were taken to nominal and rated pressures when the balloons ruptured due to the sharp calcium and/or stent struts which most likely impaled the balloons at the right rated atms (atmospheres).Multiple balloons used and broke during procedure.Everything removed from body.No bad outcomes.
 
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Brand Name
SPRINTER®
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC.
37a cherry hill dr
danvers MA 01923
MDR Report Key7205352
MDR Text Key97754641
Report Number7205352
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2018
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberSPR1512W
Device Catalogue NumberSPR1512W
Device Lot Number8861754
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/17/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer01/17/2018
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) Other;
Patient Age62 YR
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