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 No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A pressurewire aeris encountered difficulty crossing a lesion in the mid rca, partially due to steerability issues.A non-sjm soft.014mm buddy wire was inserted successfully through the lesion to help the pressurewire, but when attempting to again advance the pressurewire, it was unsuccessful.Then, when an attempt was made to retract the pressurewire, it met resistance.The device released shortly thereafter, however, the distal portion of the pressurewire broke off and remained in the rca.The buddy wire was removed without incident.The patient was transferred to another facility where the fragment was successfully snared from the sub-intimal space.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Evaluation summary: the results of the investigation concluded the corewire was fractured at the distal tip and the tip coil was fractured at the weld joint and separated from the guidewire; both corewire sections were bent at the location of the break.The combined length of the two corewire sections indicated there was no missing material from the distal tip assembly.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 fracture and the tip coil fracture and separation at the weld joint is consistent with forcible contact during use.The results of the investigation related to the steering issue concluded there were no visual anomalies noted at the torque device; however, the radiopaque tip and shaft had been kinked.The torque device was attached to the guidewire and was manipulated; the guidewire responded accordingly and the torque driver remained firmly attached.Additional functional testing was unable to be conducted due to the guidewire distal tip damage.Although the exact cause of the reported steering issue remains unknown, the guidewire damage is consistent with the reported event.The cause of the guidewire damage is consistent with forcible contact during use.The pressurewire aeris instructions for use (ifu) cautions 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.

• 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: 5534551
• MDR Text Key: 41457197
• Report Number: 3008452825-2016-00044
• 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
• Report Date: 03/04/2016

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: 08/31/2017
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5239928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2015
• 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
• Patient Age: 57 YR