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

Model Number	C12009
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The pressurewire x, cabled was calibrated and equalized normally.While advancing the device into the lesion, the radiopaque tip part (3cm) got bent and became unable to be removed from the lesion with moderate tortuosity and mild angulation.50% stenosis was observed by cag near lad#6 mid, and ffr measurement was attempted in order to diagnose and defer pci.Since a 4fr cag catheter was used via the right radial, a 6fr guiding catheter was newly engaged from the right inguinal region and a non-abbott guidewire was re-crossed.Dilatation in the lesion with a balloon was performed, but the device could not be removed.The device was removed by force and the procedure was completed without ffr.No fragments remained in the patient.No consequences occurred on the patient.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.
Additional Manufacturer Narrative
The reported event of the stuck guidewire and distal tip coil kink was confirmed.The results of the investigation concluded that the distal tip coil and corewire had been kinked at multiple locations; the corewire and distal tip coil had also been twisted at 12mm proximal to the distal tip; both the distal tip coil and corewire remained intact.Information from the field states that the pressurewire was used with a 4f guiding catheter.The pressurewire instructions for use (ifu), 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.The cause of the stuck guidewire is consistent with the twisted and kinked section of the distal tip coil and corewire.The cause of the twisted and kinked distal tip coil and corewire is consistent with damage during use.The pressurewire x instructions for use (ifu) states that the user should advance or withdraw the pressurewire slowly and never push, withdraw or torque the pressurewire if it meets resistance.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.

• Brand Name: PRESSUREWIRE¿ X, CABLED, RX 175CM
• Common Device Name: 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: 7719201
• Report Number: 3008452825-2018-00253
• Device Sequence Number: 11201008
• Product Code: DXO
• UDI-Device Identifier: 05415067025739
• UDI-Public: 05415067025739
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: C12009
• Device Catalogue Number: C12009
• Device Lot Number: 6228600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1