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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
Medical Device Problem Code Deflation Problem (1149)
Health Effect - Clinical Codes Atherosclerosis (1728); Peripheral Vascular Disease (2002)
Date of Event 03/14/2018
Type of Reportable Event Serious Injury
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Brand Name
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
Common Device Name
DCB PTA CATHETER
Manufacturer (Section D)
SPECTRANETICS
6531 dumbarton circle
fremont CA 94555
MDR Report Key7441379
Report Number3009784280-2018-00048
Device Sequence Number1055782
Product Code ONU
UDI-Device Identifier00813132023256
UDI-Public00813132023256
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P160049
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/21/2018
Report Date (Section F) 01/01/2005
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
Operator of Device Health Professional
Device Expiration Date05/18/2018
Device Model NumberAB35SX060120135
Device Catalogue NumberAB35SX060120135
Device Lot NumberFHV17E04A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report to Manufacturer01/10/2005
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/18/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number0
Concomitant Medical Products
and Therapy/Usage Dates
ABBOTT: 0.035" BMW GUIDE WIRE; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: INTRODUCER SHEATH
Outcome Attributed to Adverse Event Required Intervention;
Date Report Sent to FDA01/01/2005
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