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

Model Number C12059

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2018

Event Type  Injury  

Event Description

Intervening over the pressurewire x, wireless, an unspecified balloon was advanced near the end of the procedure.The device snapped in half.The break was outside the patient's anatomy and the device was fully retrieved.Though requested, no patient information was provided by the site.

Manufacturer Narrative

The reported event of a guidewire fracture was confirmed.The results of the investigation concluded that the coated proximal tube (shaft) had been fractured and separated, with subsequent fracture of the microcables; the corewire remained intact.Both the distal section and proximal section of the shaft had been kinked at the location of the shaft fracture.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the guidewire damage is consistent with damage 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 the pressurewire is a delicate instrument and should be handled carefully.Bending or excessive force during removal from the packaging coil may damage the guidewire.

Event Description

Intervening over the pressurewire x, wireless, an unspecified balloon was advanced near the end of the procedure.The device snapped in half as the post dilitation balloon was being walked off.The break was at the proximal end, outside of the patient's body, and the device was fully retrieved.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.

• Brand Name: PRESSUREWIRE¿ X, WIRELESS, RX 175CM
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); 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 ; 6517564470
• MDR Report Key: 7521733
• MDR Text Key: 108496625
• Report Number: 3008452825-2018-00155
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/22/2018

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: 12/31/2019
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 6262750
• Other Device ID Number: 05415067025715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/03/2018
• 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