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

Model Number C12059

Device Problems Fracture (1260); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2017

Event Type  malfunction  

Event Description

There was strong resistance felt when the x, wireless was inserted through a 5f cag catheter to the equalization point.When the pressure wire was removed, it was found fractured near the distal portion of the coated distal tube.The fractured portion of the device remained inside the catheter and was removed with the cag catheter.No fragments remained in the patient.Another pressure wire was used to complete the procedure, along with a new catheter and y-connector.It was reported the device may have been advanced inside the catheter with a bent shape to the tip, which could have caused the resistance.

Manufacturer Narrative

The results of the investigation concluded that the hydrophilic coated distal tube had been torn, with subsequent fracture of the microcables and corewire; the microcables and corewire were exposed.The combined length of the two returned guidewire sections indicated that there was no missing material from the guidewire assembly.There were multiple kinks and bends throughout the guidewire.The tip coil outside diameter remains inconclusive due to the tip coil damage.The dimensional inspection revealed the coated proximal tube outside diameter met specification.Information from the field states that the pressurewire was used with a 5f catheter, which is inconsistent with the pressurewire instruction for use (ifu).According to the ifu, the pressurewire should be used in conjunction with 6f (2 mm diameter) guiding catheter.The device met specifications prior to leaving abbott manufacturing facilities as supported by a review of the device history record.The cause of the reported insertion difficulty is consistent with the incorrect catheter size used.The cause of the guidewire damage is consistent with forcible contact during use.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.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.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 6734185
• MDR Text Key: 80752504
• Report Number: 3008452825-2017-00164
• Device Sequence Number: 1
• Product Code: DXO
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 5891379
• Other Device ID Number: 05415067025715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 08/18/2017
• Supplement Dates FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• 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): Other
• Patient Age: 78 YR