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

Model Number C12058

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/21/2017

Event Type  Injury  

Manufacturer Narrative

Voluntary medwatch number: mw5072778.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.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.

Event Description

During the process to place stent using the pressurewire aeris agile tip, the distal portion of the wire tip measuring approximately 3 cm dislodged.The tip of the wire was successfully jailed with the implantation of 3 additional drug-eluting stents in the rca territory.Diagnosis or reason for use: obstructive coronary disease in rca.Patient was discharged same day with no complications after the stent placement.

Manufacturer Narrative

The reported event of the distal tip coil fracture was confirmed.The results of the investigation concluded that the distal tip coil had been fractured and separated from the distal end of the 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 returned length of the distal corewire indicated there was missing material from the distal tip assembly.There was evidence of the tip coil proximal weld joint.Additional analysis revealed that the guidewire was exposed to excessive torqueing and manipulation.Torqueing or excessive manipulation of the guidewire in a sharp bend, against resistance, or repeated attempts to cross a total vessel occlusion may damage and/or fracture the pressurewire, which is inconsistent with the instructions for use (ifu).The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the distal tip coil and corewire damage is consistent with forcible contact during use.

• 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: 7016195
• MDR Text Key: 91745937
• Report Number: 3008452825-2017-00280
• 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: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

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: 07/31/2018
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5617154
• Other Device ID Number: 05414734055772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2016
• 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
• Patient Age: 53 YR
• Patient Weight: 80