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

Model Number C12008

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During advancement of the pressurewire certus into the lesion, the distal tip broke.The tip was removed using a snare, and the procedure was completed with another pressurewire certus.The patient was stable.

Manufacturer Narrative

Product evaluation: the results of the investigation concluded that the tip coil of the radiopaque tip had been fractured and separated from the distal end sensor element (jacket); the fractured tip coil was not returned.The corewire had been subsequently fractured.The distal portion of the fractured corewire was not returned.The device met specifications prior to leaving abbott manufacturing facilities as supported by a review of the device history record.The cause of the tip coil and corewire damage is consistent with forcible contact.How or when the forcible contact occurred 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: PRESSURE WIRE CERTUS G8
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): ST. JUDE MEDICAL; 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; 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: 6272589
• MDR Text Key: 65588694
• Report Number: 3008452825-2017-00010
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K131452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• 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: C12008
• Device Catalogue Number: C12008
• Device Lot Number: 5600991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2016
• 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): Required Intervention