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

Model Number C12058

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/13/2017

Event Type  Injury  

Event Description

The pressurewire aeris was placed in the pda and two stents were deployed.As the pressurewire aeris was being removed from the anatomy the coil came off in the left pda and it took 3 hours to snare the coils.There was no part of the device left in the anatomy.There was no resistance noted when removing the wire.But the physician thinks the coils might have been trapped in the distal architecture of the vessel.The procedure was completed and the patient was fine when he went to recovery.The only patient information given was that the patient was male.Further information was not provided due to hospital privacy policy.

Manufacturer Narrative

Product evaluation: the reported event of "the tip coil came off" was not confirmed.The results of the investigation concluded that the tip coil damage was unable to be determined; however, the hydrophilic coated distal tube, microcables, and corewire had been fractured.The fractured guidewire section was not returned.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the tip coil damage remains unknown; however, the hydrophilic coated distal tube, microcables, and tip coil damage is consistent with forcible contact during use.The pressurewire instructions for use (ifu) states that excessive manipulation of the pressurewire when the sensor element or pressurewire tip is located in sharp bend may cause damage or tip fracture.The pressurewire instructions for use (ifu) states that the pressurewire is a delicate instrument and should be handled carefully.Bending or excessive force during removal from the packaging coil may damage the guidewire.The pressurewire instructions for use (ifu) states that torqueing the pressurewire against resistance or repeated attempts to cross a total vessel occlusion may cause damage and/or fracture, which may lead to a portion of pressurewire separating from the tip.The pressurewire instructions for use (ifu) states that the user should advance or withdraw the pressurewire slowly and never push, withdraw or torque the pressurewire if it meets resistance.

• 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 ; 6517564470
• MDR Report Key: 7121921
• MDR Text Key: 94988936
• Report Number: 3008452825-2017-00338
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 6013872
• Other Device ID Number: 05414734055772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2017
• 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
• Patient Outcome(s): Other; Required Intervention