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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 Consequences Or Impact To Patient (2199)
Event Date 05/11/2020
Event Type  malfunction  
Manufacturer Narrative
One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.Optical fibers 1-3 met specifications for optical properties and contact force was displayed when the returned device was connected to the tactisys unit, with no error messages noted.The device met specifications during temperature testing.However, multiple short circuits were detected during electrical testing.Fluid was noted outside of the irrigation tubing but within the tygon tubing proximal to the catheter handle and the device did not meet specifications during an irrigation leak test.In addition, dried saline was noted within the connector plug, consistent with the short circuits detected.Further testing revealed a gap in the adhesive between the irrigation tube and the proximal tube inside the luer lock, allowing fluid to flow outside of the irrigation tubing and into the proximal tubing towards the optical and electrical connectors, consistent with the dried saline noted within connector plug and the failed irrigation leak test.
 
Event Description
This report is to advise of an event observed during analysis confirming an irrigation leak and 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 Key10282226
MDR Text Key199261658
Report Number9680001-2020-00038
Device Sequence Number1
Product Code OAE
UDI-Device Identifier07640157990040
UDI-Public07640157990040
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 07/16/2020
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 Date08/25/2021
Device Model NumberPN-004 075
Device Catalogue NumberPN-004075
Device Lot Number6965129
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/30/2020
Initial Date FDA Received07/16/2020
Date Device Manufactured09/24/2019
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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