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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 Problems Fluid/Blood Leak (1250); Electrical Shorting (2926)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2023
Event Type  malfunction  
Manufacturer Narrative
One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.Optical fibers 1 and 2 no longer met specifications for optical properties and no contact force was displayed when the returned device was connected to the tactisys quartz unit.The device did not meet specifications during a shaft leak test and an irrigation leak test.Additionally, multiple short circuits were detected.Further investigation revealed a leak at the irrigation tubing and tip assembly junction due to the pi irrigation tubing detaching from the metal irrigation tubing, consistent with the failed shaft and irrigation leak tests, fluid ingress, observed short circuits, and a loss of force data during the procedure.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The root cause of the detached pi irrigation tubing was determined to be supplier related.Abbott is continuing to monitor the reported issue.
 
Event Description
(b)(6) 2023 (b)(6) - this report is to advise of fluid leak and multiple short circuits noted during analysis.
 
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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 Key16674741
MDR Text Key312636579
Report Number9680001-2023-00019
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 04/04/2023
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 Date05/25/2023
Device Model NumberPN-004 075
Device Catalogue NumberPN-004075
Device Lot Number7526113
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/31/2023
Initial Date FDA Received04/04/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2021
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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