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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, PTCA, CUTTING/SCORING
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SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, PTCA, CUTTING/SCORING Back to Search Results
Model Number 2200-3015
Device Problem Detachment Of Device Component (1104)
Patient Problems Atherosclerosis (1728); Ischemic Heart Disease (2493)
Event Date 03/06/2018
Event Type  Injury  
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Brand Name
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
Type of Device
CATHETER, PTCA, CUTTING/SCORING
Manufacturer (Section D)
SPECTRANETICS
5055 brandin court
fremont CA 94538
Manufacturer (Section G)
SPECTRANETICS
5055 brandin court
fremont CA 94538
Manufacturer Contact
florie cazem
5055 brandin court
fremont, CA 94538
510933-792
MDR Report Key7384191
Report Number3005462046-2018-00006
Device Sequence Number1
Product Code NWX
UDI-Device Identifier00813132021214
UDI-Public00813132021214
Reporter Country CodeKS
PMA/PMN Number
P050018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Physician
Type of Report Initial
Report Date 01/01/2005,03/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date04/26/2020
Device Model Number2200-3015
Device Catalogue Number2200-3015
Device Lot NumberG17040053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2018
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
Date Manufacturer Received03/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2017
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
BOSTON: 3.0X15 GUIDEZILLA EXTENSION CATHETER; MEDTRONIC: 7F LAUNCHER GUIDE CATHETER; TERUMO: 0.014" GUIDE WIRE; TERUMO: 7F INTRODUCER SHEATH
Patient Outcome(s) Required Intervention;
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