Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, PTCA, CUTTING/SCORING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, PTCA, CUTTING/SCORING Back to Search Results
Model Number 2200-3010
Medical Device Problem Codes Detachment Of Device Component (1104); Retraction Problem (1536)
Health Effect - Clinical Codes Atherosclerosis (1728); Ischemic Heart Disease (2493)
Date of Event 05/30/2018
Type of Reportable Event Malfunction
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
Common Device Name
CATHETER, PTCA, CUTTING/SCORING
Manufacturer (Section D)
SPECTRANETICS
5055 brandin court
fremont CA 94538
MDR Report Key7617709
Report Number3005462046-2018-00011
Device Sequence Number13891938
Product Code NWX
UDI-Device Identifier00813132021207
UDI-Public00813132021207
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P050018
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 05/31/2018
Report Date (Section F) 01/01/2005
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/09/2021
Device Model Number2200-3010
Device Catalogue Number2200-3010
Device Lot NumberG18030014
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 Date06/19/2018
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: 0.014" GUIDE WIRE; CORDIS: 6F GUIDE CATHETER; CORDIS: 6F INTRODUCER SHEATH; VASCULAR SOLUTIONS: 6F GUIDELINER
Outcome Attributed to Adverse Event Other;
Date Report Sent to FDA01/01/2005
-
-