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

Model Number C12059

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2018

Event Type  Injury  

Manufacturer Narrative

The reported event of a stuck guidewire and positioning issue was confirmed.The results of the investigation concluded that the distal tip coil had been stretched and bent; the corewire and distal tip coil remained intact.Information from the field states that the pressurewire was used with a 4f guiding catheter.The pressurewire instructions for use (ifu) artmt100141883, rev.B, directs the user to use the pressurewire guidewire in conjunction with a 6f (2 mm diameter) guiding catheter.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Although the exact cause of the stuck guidewire and positioning issue remains unknown, the bent and stretched distal tip coil is consistent with the reported event.The cause of the bent and stretched distal tip coil is consistent with damage during use.The pressurewire ifu states that a guiding catheter with a 6f (2 mm) size or larger should be used to prevent damping of the aterial pressure signal.Larger size should be considered when large interventional catheters are used.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.

Event Description

The pressurewire x, wireless was used; moderate angulation, moderate tortuosity, and severe calcification were noted.Initially, a 4fr guiding catheter was used.There was resistance felt while advancing the device and it felt as if the tip of the device got trapped in the lesion.On angiogram, the tip of the device appeared to be wrapped up.It was attempted to pull out the device slowly, but although the proximal part of device could be pulled out, it was confirmed on the cine image that the tip remained trapped and did not move.A non-abbott guidewire was twined around the device, but the it still could not be pulled out.While attempting to change the cag catheter to 6fr guiding catheter, the device became dislodged and could be pulled out.No consequences occurred on the patient.The procedure was completed without measuring ffr.Additional information is not expected.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; 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: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7819633
• MDR Text Key: 118333358
• Report Number: 3008452825-2018-00287
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2018

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: 03/31/2020
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 6416183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2018
• 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