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

Model Number C12058

Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260); Material Fragmentation (1261); Migration or Expulsion of Device (1395)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Ffr was performed on an lad lesion using a pressurewire aeris.While attempting to advance the wire down the lad, the wire directed into what appeared to be a small side branch.The wire met minimal resistance and was pulled back in order to redirect into the main body of the lad.At this point, the distal end of the wire would not pull back.The wire was attempted to be spun and torqued, but at this point a portion of the distal end of the wire broke off and embolized in the mid portion of the lad.The patient required resuscitation and was intubated approximately 10 minutes after the wire broke off in the vessel.The physician was unable to retrieve the wire.The wire was stabilized by stenting the vessel and trapping the wire between the stent and the vessel wall.The physician stated that he considered the patient stable, and the patient was transferred to the icu.The patient was discharged in stable condition on (b)(6) 2016.

Manufacturer Narrative

(b)(4).Product evaluation: the results of the investigation concluded that the tip coil of the radiopaque tip had been fractured and not returned, which exposed the corewire.The corewire was fractured into two sections at the distal tip.The distal section of the corewire was not returned; the measured corewire proximal section indicated there was a missing material from the distal tip assembly.The shaft had been bent at multiple locations.One customer image was received.Although the exact cause of the reported event remains unknown, the guidewire damage is consistent with the reported positioning issue and fracture.The device met specifications prior to leaving sjm manufacturing facilities as supported by a review of the device history record.The cause of the guidewire damage is consistent with forcible contact during use.The pressurewire aeris instructions for use (ifu) states that potential complications which may be encountered during all catheterization procedures include but are not limited to: vessel dissection or occlusion, perforation, embolus, spasm, local and/or systemic infection, pneumothorax, congestive heart failure, myocardial infarction, hypotension, chest pain, renal insufficiency, serious arrhythmias or death.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 torquing 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.

Manufacturer Narrative

Medwatch number: (b)(4).(b)(4).

Event Description

The patient underwent an elective percutaneous coronary intervention.The mid-lad had intermediate stenosis in the mid-portion of the vessel.Ffr was performed on an lad lesion using a pressurewire aeris.It was reported that due to the patient's coronary anatomy, there was difficulty accessing the desired location in the mid-lad.The wire was repeatedly withdrawn and manipulated and redirected to reach the designated location in the mid-lad.While attempting to advance the wire down the lad, the wire directed into what appeared to be a small side branch.The wire met minimal resistance and was pulled back in order to redirect into the main body of the lad.At this point, the distal end of the wire would not pull back.The wire was attempted to be spun and torqued, but at this point a 3cm portion of the distal end of the wire broke off and embolized in the mid portion of the lad.When the pressurewire was withdrawn from the patient, the distal portion of the wire remained in the patient's vessel.The patient required resuscitation and was intubated approximately 10 minutes after the wire broke off in the vessel.The physician was unable to retrieve the wire.The wire was stabilized by stenting the vessel and trapping the wire between the stent and the vessel wall.The physician stated that he considered the patient stable, and the patient was transferred to the icu.The patient was discharged in stable condition on (b)(6) 2016.

• 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: 6198409
• MDR Text Key: 63091849
• Report Number: 3008452825-2016-00183
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5596944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 99