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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPECTRANETICS STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON; DCB PTA CATHETER
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SPECTRANETICS STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON; DCB PTA CATHETER Back to Search Results
Model Number AB35SX060120135
Device Problem Deflation Problem (1149)
Patient Problems Atherosclerosis (1728); Peripheral Vascular Disease (2002)
Event Date 03/14/2018
Event Type  Injury  
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Brand Name
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
Type of Device
DCB PTA CATHETER
Manufacturer (Section D)
SPECTRANETICS
6531 dumbarton circle
fremont CA 94555
Manufacturer (Section G)
SPECTRANETICS
6531 dumbarton circle
fremont CA 94555
Manufacturer Contact
florie cazem
5055 brandin court
fremont, CA 94538
510933-792
MDR Report Key7441379
Report Number3009784280-2018-00048
Device Sequence Number1
Product Code ONU
UDI-Device Identifier00813132023256
UDI-Public00813132023256
Reporter Country CodeUS
PMA/PMN Number
P160049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/01/2005,03/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/18/2018
Device Model NumberAB35SX060120135
Device Catalogue NumberAB35SX060120135
Device Lot NumberFHV17E04A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/18/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number0
Treatment
ABBOTT: 0.035" BMW GUIDE WIRE; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: INTRODUCER SHEATH
Patient Outcome(s) Required Intervention;
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