MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA PRESSUREWIRE¿

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

Patient Problem Ischemia (1942)

Event Date 11/07/2017

Event Type  Injury  

Event Description

The reported issue occurred following use of a pressure wire; however it is unknown at this time which artery the pressure wire was used in or if the pressure wire was used in the femoral artery.Previous patient history indicated the patient had a coronarography on (b)(6) 2017 for acute coronary syndrome that was complicated by a pseudoaneurysm of the left scarpa, which led to major lesions of the femoral tripod and required a reconstruction of the iliofemoral and a deep left femoral bypass in the saphenous vein.It was reported the first symptom in the left lower limb was on (b)(6) 2017.At that time, an ultrasound doppler was performed.On (b)(6) 2017, the patient presented with critical ischemia with trophic trouble of the left lower limb.On (b)(6) 2017 a left superficial femoral recanalization by cross-over and stent were performed.It was also reported a left trans-metatarsal amputation was performed during the hospital stay.The patient recovered on (b)(6) 2017 and was discharged on (b)(6) 2017.((b)(6) clinical study (b)(6)).

Manufacturer Narrative

An event of critical ischemia with trophic trouble of the left lower limb was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record could not be reviewed since a lot/batch number was not available.Based on the information received, the cause of the reported incident could not be conclusively determined.The pressurewire instructions for use (ifu) states that potential complications which may be encountered during all catheterization procedures include vessel occlusion.

• Brand Name: PRESSUREWIRE¿
• Type of Device: PRESSUREWIRE
• 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 ; 6517565400
• MDR Report Key: 7163899
• MDR Text Key: 96353817
• Report Number: 3008452825-2018-00006
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR