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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, 65MM; 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, 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 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 65 mm tacticath quartz contact force ablation catheter was received for evaluation.Room temperature water was cycled through the device with a cool point pump and a leak was noted at the luer/irrigation tubing junction.Microscopic inspection revealed the irrigation luer is concentric within the luer hub, however, the luer appeared to be damaged.The luer hub was visually inspected, confirming a small gap between the cured adhesive and inner irrigation tubing.Fluid was noted outside of the irrigation tubing but within the tygon tubing proximal to the catheter handle.The root cause of the leak at the luer/irrigation tubing junction remains unknown.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
 
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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 Key13456716
MDR Text Key288659600
Report Number9680001-2022-00007
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 Physician
Type of Report Initial
Report Date 02/04/2022
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 Date10/25/2022
Device Model NumberPN-004 065
Device Catalogue NumberPN-004065
Device Lot Number7525987
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/26/2022
Initial Date FDA Received02/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2020
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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