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

Model Number C12008

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 04/16/2015

Event Type  Injury  

Event Description

When advancing a pressurewire certus in the calcified left anterior descending artery (lad), in combination with a balloon, the distal tip of the pressurewire broke due to possible kinking or looping.The physician withdrew the pressurewire and balloon, noting the tip of the pressurewire was in the distal end of the lad.The proximal half of the detached tip was stented in the lad, while the distal half was located in the marginal side branch artery.An attempt was made to remove the tip, but was unsuccessful since the fragment was stuck in the marginal side branch.A stent was inserted to hold the fragment in place.The procedure was aborted and the patient is currently in stable condition.

Manufacturer Narrative

(b)(4).Product evaluation: the results of the investigation concluded that the coated distal tube, corewire and microcables had been detached.The detached portion was not returned.The device met specifications prior to leaving sjm manufacturing facilities as supported by the device history record.There was no evidence to suggest there was an intrinsic defect in the pressurewire.The guidewire detachment is consistent with damage 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 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

(b)(4).

• Brand Name: PRESSURE WIRE CERTUS 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 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 1897 -405; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4760493
• MDR Text Key: 5784117
• Report Number: 3008452825-2015-00026
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K131452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2015

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: 08/31/2016
• Device Model Number: C12008
• Device Catalogue Number: C12008
• Device Lot Number: 4790182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 05/08/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/04/2015; 06/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2014
• 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