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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); Material Frayed (1262); Electrical Shorting (2926)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/19/2019
Event Type  malfunction  
Manufacturer Narrative
One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.Log file analysis indicates fibers 1-3 no longer met specifications and contact force was lost.A blood-like substance was present within the distal shaft of the catheter and the shaft material was fractured at the proximal end of the deflectable section of the shaft, exposing the inner components of the catheter.The tip thermocouple read as an open circuit and multiple short circuits were noted due to fluid ingress at the fractured shaft portion.Additionally, an irrigation leak was noted at the aforementioned shaft fracture due to a fracture in the irrigation tubing.The exact cause of the shaft fracture could not be determined.The cause of the reported contact force issue is consistent with fluid ingress; however, the cause remains unknown due to the condition of the returned device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
 
Event Description
This report is to advise of an event observed during analysis confirming exposed internal components and a short circuit of the catheter.
 
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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
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key10366673
MDR Text Key201875594
Report Number9680001-2020-00041
Device Sequence Number1
Product Code OAE
UDI-Device Identifier07640157990040
UDI-Public07640157990040
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P130026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 08/05/2020
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 Date12/25/2020
Device Model NumberPN-004 075
Device Catalogue NumberPN-004075
Device Lot Number6765202
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/29/2020
Initial Date FDA Received08/05/2020
Date Device Manufactured01/30/2019
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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