MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA PRESSURE WIRE AERIS G8; TRANSDUCER, PRESSURE,CATHETER TIP

Model Number C12058

Device Problems Kinked (1339); No Device Output (1435)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2017

Event Type  Injury  

Event Description

The pressurewire aeris was calibrated an equalized successfully.After the device was crossed into the distal lad through heavy tortuosity and heavy calcification, it was noticed there was no pd signal.When the device was removed from the patient, there was a kink noted at the proximal end of the pressurewire.The procedure was postponed until the next week, and ffr and pci was then completed successfully.Patient information could not be provided due to personal data privacy legislation/policy.

Manufacturer Narrative

The reported event of signal loss could not be confirmed; however, the reported event of kink was confirmed.The results of the investigation confirmed the pressurewire met functional specifications when analyzed for the reported signal loss.Visual inspection confirmed that the male connector and the shaft had been kinked.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported signal loss remains unknown; however, the guidewire damage is consistent with forcible during use.The pressurewire instructions for use (ifu) cautions that if the guidewire is damaged during the procedure, to immediately disconnect the transmitter and replace the damaged device.(damage may include but is not limited to bends/kinks or no pressure signal).

• Brand Name: PRESSURE WIRE AERIS G8
• 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: 7117586
• MDR Text Key: 94849877
• Report Number: 3008452825-2017-00334
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K131452
• 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: 01/10/2018

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
• Device Expiration Date: 10/31/2018
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5743358
• Other Device ID Number: 05414734055772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/14/2017
• Supplement Dates Manufacturer Received: 01/09/2018
• Supplement Dates FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2016
• 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