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

Model Number C12059

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

The pressurewire x, wireless was used in the procedure and broke inside the patient anatomy.The detached component remained in the guide catheter and was retrieved.Another pressurewire x, wireless was used to complete the procedure.No further information available.Patient's information (e.G.Age, weight, gender, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.

Manufacturer Narrative

The reported event of a 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 corewire was also fractured.There was evidence of the tip coil proximal weld joint.The returned length of the corewire indicated that there was no missing material from the distal tip assembly.There were multiple bends throughout the guidewire, consistent with the guidewire being exposed to excessing torqueing and manipulation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Although the exact cause of the reported event remains unknown, the guidewire damage is consistent with forcible contact during use.The pressurewire x 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 x 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
• MDR Report Key: 7617033
• MDR Text Key: 111609863
• Report Number: 3008452825-2018-00182
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K161171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 6262746
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 11/02/2018
• Supplement Dates FDA Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention