MAUDE Adverse Event Report: ST. JUDE MEDICAL PRESSUREWIRE X, WIRELESS, RX 175CM; WIRE, GUIDE, CATHETER

Model Number C12059

Device Problem Difficult to Insert (1316)

Patient Problem Vasoconstriction (2126)

Event Date 03/29/2021

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, the cause of the reported incident could not be conclusively determined.

Event Description

During the procedure, the device could not cross the right coronary artery lesion and caused a severe spasm.The spasm made it difficult to remove the guidewire from the lesion into the guide.The device was re-wired with another guidewire and resting full-cycle ratio (rfr) was performed.A physiologic assessment of the lesion could not be performed.Based on angiography only, it was decided not to intervene and the case was ended.

• Brand Name: PRESSUREWIRE X, WIRELESS, RX 175CM
• Type of Device: WIRE, GUIDE, 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; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, MA 92591 ; 9519143996
• MDR Report Key: 11715725
• MDR Text Key: 246987011
• Report Number: 3008452825-2021-00238
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161171
• 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
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 7137041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2019
• 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