• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENUSA DE MEXICO S.A. DE C.V. TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

  • 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
 

VENUSA DE MEXICO S.A. DE C.V. TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Model Number PN-004 065
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2022
Event Type  malfunction  
Manufacturer Narrative
One 65 mm tacticath quartz contact force ablation catheter was received for evaluation.The catheter met specifications during electrical testing, temperature testing, and shaft leak testing.The catheter did not meet specifications during irrigation leak testing, but no fluid ingress was noted into the distal shaft, proximal tubing, or handle.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the leak test remains unknown.
 
Event Description
This report is to advise of an event observed during analysis confirming an irrigation leak of the catheter.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
Manufacturer (Section D)
VENUSA DE MEXICO S.A. DE C.V.
calle hertz 1525-6
parque industrial j. bermudez
ciudad juarez, chihuahua 32470
MX  32470
Manufacturer (Section G)
VENUSA DE MEXICO S.A. DE C.V.
calle hertz 1525-6
parque industrial j. bermudez
ciudad juarez, chihuahua 32470
MX   32470
Manufacturer Contact
janna parks
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key14487469
MDR Text Key292490535
Report Number9680001-2022-00021
Device Sequence Number1
Product Code OAE
UDI-Device Identifier07640157990033
UDI-Public07640157990033
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P130026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/25/2022
Device Model NumberPN-004 065
Device Catalogue NumberPN-004065
Device Lot Number7423871
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/29/2022
Initial Date FDA Received05/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-