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: MERIT MEDICAL SYSTEMS, INC. PERFORMA ANGIOGRAPHIC CARDIOLOGY CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC
  • 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
 

MERIT MEDICAL SYSTEMS, INC. PERFORMA ANGIOGRAPHIC CARDIOLOGY CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number 7704-70
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/19/2014
Event Type  malfunction  
Event Description
The user reported that, during the removal of the catheter from the packaging, the tip of the catheter became disconnected.The device was not used on a patient.
 
Manufacturer Narrative
Device evaluation: the device is expected to be returned.A follow up report will be sent when the evaluation has been completed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PERFORMA ANGIOGRAPHIC CARDIOLOGY CATHETER
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
south jordan UT
Manufacturer Contact
jerry mcphie
1600 west merit parkway
south jordan, UT 84095
8012084491
MDR Report Key4180763
MDR Text Key5159955
Report Number1628221-2014-00008
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K943739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 09/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2016
Device Catalogue Number7704-70
Device Lot NumberE516275
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received09/23/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-