MAUDE Adverse Event Report: ST. JUDE MEDICAL VIEWFLEX¿ XTRA ICE CATHETER

Model Number D087031

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 07/11/2017

Event Type  Injury  

Event Description

Following the procedure, a tear was noted in the inferior vena cava.After advancing the catheter into the heart, it was noted that it did not deflect as expected.The catheter was removed and replaced and the procedure was completed with no adverse consequences to the patient.Three days after the ablation procedure, a decrease in blood pressure was noted and bleeding at the inferior vena cava was confirmed with a ct scan.Medications were given to reverse the anticoagulation and a surgical closure was performed to stabilize the patient.

Manufacturer Narrative

The results of the investigation confirmed that the catheter deflected in all directions and met specifications for curve shape when actuating the steering mechanisms.The device met specifications prior to release from abbott manufacturing facilities as supported by the device history record.The cause of the reported deflection issue and subsequent bleeding at the inferior vena cava remains unknown.

Manufacturer Narrative

The results of the investigation confirmed that multiple turns were needed to fully deflect the catheter in all directions; however, the catheter deflected in all directions and met specifications for both curve shape and activation from the neutral position when actuating the steering mechanism.

Event Description

After advancing the catheter up the inferior vena cava, it was noted that the catheter was difficult to maneuver.The catheter was never advanced into the heart; it was not advanced beyond the diaphragm.The catheter was removed and replaced and the procedure was continued as expected.After removing the device from the patient, it was confirmed that it took 3-4 rotations to deflect the catheter in one direction, and 3-4 rotations in the other direction.At the end of the case, a decrease in blood pressure was noted and bleeding at the inferior vena cava was confirmed with a ct scan.The patient was medically managed with anticoagulation, blood and fresh frozen plasma (ffp).The patient was discharged a couple days later with stable hemodynamics.

Manufacturer Narrative

The reported lack of deflection response could not be confirmed.The catheter met specifications for deflection response for activation from the neutral position when actuating the steering mechanisms in all directions.In addition, the catheter fully deflected and met specifications curve shape in all directions.

Event Description

After removing the device from the patient, it was confirmed that no response was received from the catheter when creating a quarter turn for a minor deflection not full rotations as implied in the previous report.

• Brand Name: VIEWFLEX¿ XTRA ICE CATHETER
• Type of Device: ICE CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6775795
• MDR Text Key: 82105772
• Report Number: 3008452825-2017-00174
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: D087031
• Device Lot Number: 6011455
• Other Device ID Number: 05415067002082
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2017
• 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
• Patient Outcome(s): Other; Required Intervention