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

Model Number C12058

Device Problem Incorrect Measurement (1383)

Patient Problem Intimal Dissection (1333)

Event Date 02/10/2015

Event Type  Injury  

Event Description

A pressurewire aeris was calibrated and equalized normally.The transmitter was detached to deliver the pressurewire aeris to the target lesion.After the pressurewire aeris crossed the stenosis, the transmitter was reattached, and ffr measurement was carried out.However, the pressure values drifted.The pressurewire aeris was removed from the patient for recalibration, but the physician found a small dissection at the target lesion before re-inserting the pressurewire aeris.The physician decided to move on to pci without ffr measurement.The target lesion was treated with a stent, and the patient was in stable condition.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4) - atrial perforation; no known device issue.(b)(4).The pressurewire aeris was returned to sjm for analysis.Visual inspection confirmed the components were returned dry.Microscopic inspection revealed the guidewire had a dried blood-like substance and unknown foreign material visible inside the covering of the sensor element (jacket) and on the sensor chip.The guidewire had been kinked near the proximal end of the male connector.The radiopaque tip was bent at the distal tip.The coated proximal tube was twisted and partially cracked near the proximal end of the male connector; the corewire was intact.The device history record for this product was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The results of the investigation of the pressurewire aeris were inconclusive since functional testing could not be performed.The presence of a dried blood-like substance and unknown foreign material visible inside the covering of the sensor element (jacket) and on the sensor chip inherently makes signal readings unreliable, which precludes further testing.The device met specifications prior to leaving sjm manufacturing facilities as supported by the device history record.The cause of the reported signal drift remains unknown.It is uncertain when and how the arterial dissection occurred.The pressurewire instructions for use (ifu) states that vessel dissection is a potential complication which may be encountered during all catheterization procedures.The pressurewire instructions for use (ifu) states that the user should not torque the pressurewire without observing corresponding movement of the tip; otherwise vessel/ventricle trauma may occur.

• 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 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 1897 -405; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4573362
• MDR Text Key: 5547433
• Report Number: 3008452825-2015-00007
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2015

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: Physician
• Device Expiration Date: 10/31/2016
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 4869076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 03/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2014
• 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): Required Intervention