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

Model Number C12058

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During a ffr measurement, a pullback was performed in the lad with the pressure wire aeris.When the device was being repositioned back in the lad, it entered into a small side vessel.When an attempt was made to pull the wire back again, it became stuck since the vessel was small.Additional force was used to withdraw the device, and the tip of the wire, distal to the sensor element, tore off and remained in the patient's vessel.The fragment was removed and the patient is stable.

Manufacturer Narrative

(b)(4).Evalution summary: the results of the investigation concluded the corewire was fractured at the distal tip and the tip coil was fractured from the distal end of the jacket.There was evidence of the tip coil weld joint at the distal end of the jacket.The distal section of the corewire and the tip coil were not returned.Sjm also received information from the field stating that force was used to pull the device.Torqueing or excessive manipulation of the pressurewire against resistance may damage and/or fracture the pressurewire and is inconsistent with the instructions for use (ifu).The device met specifications prior to leaving sjm manufacturing facilities as supported by a review of the device history record.There was no evidence found to suggest the incident was due to an intrinsic defect in the returned device.The cause of the corewire and tip coil fracture 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 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 ; 6517565400
• MDR Report Key: 5403892
• MDR Text Key: 37300482
• Report Number: 3008452825-2016-00008
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2017
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5130691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2015
• 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
• Patient Age: 55 YR