MAUDE Adverse Event Report: VENUSA DE MEXICO S.A. DE C.V. TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number PN-004 075

Device Problem Decrease in Pressure (1490)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 10/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Related manufacturer reference 9680001-2015-00039.During a pulmonary vein isolation procedure, a cardiac tamponade occurred.A tacticath quartz ablation catheter was used to perform ablation around all four pulmonary veins.During ablation, a loss of contact force was noted and the catheter was exchanged for a second tacticath quartz ablation catheter, which also lost contact force while difficulty was encountered during catheter manipulation.Another tacticath quartz ablation catheter was used to successfully complete the ablation of the four pulmonary veins.Prior to administering adenosine to verify successfully vein isolation, shadowing around the heart and a reduction in cardiac motion were noted via fluoroscopy.The patient became hypotensive and an echocardiogram revealed a cardiac tamponade.A cardiac perforation was noted on the posterior wall of the left atrium.A pericardiocentesis was performed, which stabilized the patient.

Manufacturer Narrative

(b)(4).One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.The results of the investigation concluded that the catheter displayed acceptable optical signals when connected to the tactisys quartz unit.The device did not meet specifications during a shaft leak test and microscopic inspection of the transition between the catheter shaft and the proximal edge of the distal tip revealed part of the adhesive was no longer adhered, consistent with fluid ingress and a loss of force data during the procedure.As a result of this finding, sjm has made modifications to prevent future occurrences.It is unlikely that this finding contributed to the reported event.The device met specifications prior to leaving sjm manufacturing facilities as supported by a review of the device history record.The cause of the cardiac tamponade remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5246498
• MDR Text Key: 32064184
• Report Number: 9680001-2015-00038
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/25/2016
• Device Model Number: PN-004 075
• Device Lot Number: 4924020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: REFLEXION SPIRAL CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 94