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 Problems Chest Pain (1776); ST Segment Elevation (2059); Vascular Dissection (3160)

Event Date 06/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) 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 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.The pressurewire instructions for use (ifu) states that vessel dissection is a potential complication which may be encountered during all catheterization procedures.

Event Description

A pressurewire aeris was selected for use to perform ffr in the rca.The pressurewire aeris was connected successfully to the quantien and ao and pw zeroed.100 units of gtn were administered and the physician advanced the pressurewire through the guide catheter to the ostium of rca.Difficulty was experienced advancing the pressurewire to the eq point.When the physician attempted to rotate the pressurewire, it would not turn.The pressurewire tip appeared to be caught in the proximal lesion.When the physician pulled back slightly on the pressurewire to change its position, the wire broke off inside the plaque of the lesion.The pressurewire was removed from the patient, but upon examination, it was confirmed that 3cm of the tip was still inside the lesion of the rca.The tapered pressurewire core that was normally inside the tip was still attached to the rest of the pressurewire.The remaining portion of the tip inside the rca had expanded to a 6 cm spiral.Using 2 inflated balloons, the remained portion of the pressurewire tip was successfully removed from the patient.It was reported the patient experienced chest pain and st elevation when the pressurewire tip was first noticed to be stuck in the artery.Once the tip was removed, a dissection of the artery was noted after balloon and stent angioplasty of the affected area caused by the pressurewire tip.A stent was placed to the ostium of the rca to cover the dissection.The patient is stable now and recovering.

Manufacturer Narrative

(b)(4).The results of the investigation concluded the corewire was fractured into two sections at the distal tip, the tip coil had been fractured and separated; the corewire and shaft had been kinked.The combined length of the two corewire sections indicated there was no missing material from the distal tip assembly.There was no evidence found to suggest the incident was due to an intrinsic defect in the returned device.The device met specifications prior to leaving sjm manufacturing facilities as supported by a review of the device history record.Although the exact cause of the reported positioning issue remains unknown, the guidewire damage is consistent with the reported positioning issue.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 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.The pressurewire instructions for use (ifu) states that vessel dissection is a potential complication which may be encountered during all catheterization procedures.

• 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: 5760090
• MDR Text Key: 48504132
• Report Number: 3008452825-2016-00088
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/17/2016

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: 11/30/2017
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5327455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2016
• Initial Date FDA Received: 06/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• 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: 80 YR