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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, 75MM; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

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VENUSA DE MEXICO S.A. DE C.V. TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Model Number PN-004 075
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2021
Event Type  malfunction  
Event Description
This report is to advise of an event observed during analysis confirming an irrigation leak of the catheter.
 
Manufacturer Narrative
One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.The device did not meet specifications during an irrigation leak and shaft leak test.Further investigation revealed the shaft material and the inner irrigation tubing were damaged at the bend in the distal shaft, consistent with fluid ingress into the distal shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of leak could not be conclusively determined.
 
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Brand Name
TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM
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 Key13552287
MDR Text Key287608606
Report Number9680001-2022-00006
Device Sequence Number1
Product Code OAE
UDI-Device Identifier07640157990040
UDI-Public07640157990040
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 Physician
Type of Report Initial
Report Date 02/17/2022
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 Date12/25/2021
Device Model NumberPN-004 075
Device Catalogue NumberPN-004075
Device Lot Number7300905
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/27/2022
Initial Date FDA Received02/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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