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 Device Embedded In Tissue or Plaque (3165)

Event Date 02/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

While withdrawing a pressure wire aeris guidewire from the lad after ffr, the mid distal 5cm end of the guidewire was partially broken while inside the patient's lad.Resistance was felt while manipulating the pressure wire.On (b)(6) 2016, the guidewire piece was going to be extracted from the lad, but angiography showed that the guidewire piece was located in the femoral artery.Surgery was performed to successfully remove the guidewire piece from the patient, and the patient is stable.

Manufacturer Narrative

(b)(4).Product evaluation: the results of the investigation concluded that the tip coil of the radiopaque tip had been fractured and separated from the sensor element (jacket) distal end; the tip coil had been kinked and a portion had been stretched.The corewire had been subsequently fractured and separated in 2 sections.The proximal and distal section of the fractured corewire was returned attached to the distal end of the jacket and tip coil distal tip, respectively.The combined length of the two corewire sections indicated there was no missing material from the distal tip assembly.There were multiple kinks throughout the ptfe coated proximal tube.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.Although the cause of the reported event remains unknown, the cause of the reported positioning issue is consistent with the guidewire damage.The cause of the guidewire 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 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.

Event Description

Surgery (wrap and lasso technique).

• 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 (CVD); 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: 5448330
• MDR Text Key: 38628503
• Report Number: 3008452825-2016-00021
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/03/2016

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: 09/30/2017
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5271124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 02/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2015
• 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): Hospitalization; Required Intervention