MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA 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 05/16/2018

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received from the physician, the cause of the reported dissection may have been caused by the use of the short sheath with the ice catheter.

Event Description

During a left atrial appendage occlusion procedure a dissection occurred.During the procedure, while inserting the ice catheter through a short sheath in the femoral vein, resistance was noted.The catheter was removed and the vessel was l viewed under fluoroscopy revealing a dissection.The procedure was stopped and the patient was transferred to another department for recovery.The procedure was rescheduled.There were no performance issues with any abbott device.The physician believes the dissection may have been the result of the user, and the use of the short sheath with the catheter.

• Brand Name: VIEWFLEX¿ XTRA ICE CATHETER
• Type of Device: ICE CATHETER
• Manufacturer (Section D): 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 (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: 7605246
• MDR Text Key: 111172054
• Report Number: 3008452825-2018-00172
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 05415067002082
• UDI-Public: 05415067002082
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K121381
• 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
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: D087031
• Device Lot Number: 6296009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2018
• 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