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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 2001-3520
Device Problem Burst Container or Vessel (1074)
Patient Problem Atherosclerosis (1728)
Event Date 05/17/2018
Event Type  malfunction  
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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 Key7653989
Report Number3005462046-2018-00013
Device Sequence Number1
Product Code NWX
UDI-Device IdentifierM3702001352011
UDI-PublicM3702001352011
Reporter Country CodeCO
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 01/01/2005,05/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/15/2020
Device Model Number2001-3520
Device Catalogue Number2001-3520
Device Lot NumberF17060032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2018
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 Received06/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2017
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
UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
Patient Outcome(s) Other;
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