MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA PRESSUREWIRE¿ X, WIRELESS, RX 175CM; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number C12059

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

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 04/06/2017

Event Type  Death  

Event Description

The patient received coronary angiograph and angioplasty on both (b)(6) 2017.The pressurewire x, wireless was used for ffr measurement on (b)(6) 2017 in both the lad and the proximal circumflex, and ballooning and stenting was performed in both locations without issue.Prior to the procedure, it was reported there was 50% stenosis on lad 1, 50% stenosis on lad2, and 70% stenosis in the proximal circumflex.

Event Description

The patient received coronary angiograph and angioplasty on both (b)(6) 2017.The pressurewire x, wireless was used for ffr measurement on (b)(6) 2017 in both the lad and the proximal circumflex, and ballooning and stenting was performed in both locations without issue.Prior to the procedure, it was reported there was 50% stenosis on lad 1, 50% stenosis on lad2, and 70% stenosis in the proximal circumflex.

Event Description

The patient had experienced brutal syncope and lack of spontaneous breath.Resuscitation attempts were made (including cpr, external electrical shock, orotracheal intubation, adrenaline administration) however there was no response.The diagnostic hypothesis following the death indicated cardiac rhythm issues following a recent myocardiac infarction.

Event Description

The final diagnosis was reported to be probable atrial fibrillation, which occurred on (b)(6) 2017.

• Brand Name: PRESSUREWIRE¿ X, WIRELESS, RX 175CM
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• 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: 6962214
• MDR Text Key: 89740410
• Report Number: 3008452825-2017-00251
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K161171
• 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,Followup,Followup
• Report Date: 12/07/2017

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
• Device Expiration Date: 12/31/2018
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 5824454
• Other Device ID Number: 05415067025715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 10/24/2017; 11/27/2017; 12/04/2017
• Supplement Dates FDA Received: 11/02/2017; 12/01/2017; 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2017
• 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
• Treatment: BRILIQUE; CARDENSIEL; KARDEGIC
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Weight: 82