MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA PRESSUREWIRE¿ X, WIRELESS, RX 175CM; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number C12059

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/12/2017

Event Type  Injury  

Event Description

Pre-stent ffr measurement with the pressurewire x, wireless was performed on subtotal occlusion prox-mid lad with calcified diffuse lesion.With significant ischemic lesion, the lad was treated successfully using the pressurewire to deliver non-abbott balloons with 2 des stents deployment.During withdrawal of the pressurewire from the lad, the tip of the device separated leaving behind a fragment at the proximal lad.The separated pressurewire tip was successfully snelled out from the lad without any complication.Patient information cannot be provided due to personal data privacy legislation/policy.

Manufacturer Narrative

Product evaluation: the reported event of "tip of the device separating from the device" could not be confirmed.The results of the investigation concluded that the tip coil had been bent and stretched; however, the tip coil remained intact and attached to the distal end of the jacket.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported tip coil damage is consistent with damage during use; however, the cause of the "tip separating from the device" remains unknown.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.

• Brand Name: PRESSUREWIRE¿ X, WIRELESS, RX 175CM
• 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: 7064937
• MDR Text Key: 93134384
• Report Number: 3008452825-2017-00294
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K161171
• 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: 01/17/2018

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: 02/28/2019
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 6055359
• Other Device ID Number: 05415067025715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 11/28/2017
• Supplement Dates Manufacturer Received: 01/17/2018
• Supplement Dates FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2017
• 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