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

Model Number C12059

Device Problems Entrapment of Device (1212); Fracture (1260); Delamination (2904)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event of the guidewire stuck and ¿device was stretched and the corewire inside the device was exposed¿ was confirmed.The pressurewire had been returned inserted into the inner lumen of the balloon catheter.The coated proximal tube had been fractured, with subsequent fracture of the microcables; the corewire was exposed but remained intact.The distal tip coil, hydrophilic coated distal tube and distal shaft remained intact.The guidewire could not be removed from the balloon catheter without causing additional damage to the returned devices.The coated proximal tube outside diameter measurement was consistent with manufacturing specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Although the exact cause of the reported event of the guidewire stuck remains unknown, the guidewire damage is consistent with the reported event.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.The pressurewire instructions for use (ifu) instructs to confirm the compatibility of pressurewire diameter with the interventional device before actual use.

Event Description

The pressurewire x, wireless performed the first ffr measurement normally in the lcx, via radius approach, using 6fr guiding catheter.The procedure then moved on to pci and after pre-dilatation with poba, stenting was performed.The device got stuck in the system when attempting to withdraw the stent delivery system.The tip of the device was stretched and the corewire inside the device was exposed.The device was removed with the stent delivery system all at once.It was also noted that the lesion was in lcx #13 and was without any tortuosity or calcification.No fragments remained in the patient.No patient consequences occurred.A non-abbott device was used to continue and complete the procedure.Additional information is not expected.Patient specific information of patient identifier, age or birthdate, and weight are not available for this complaint.

• 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: 7370640
• MDR Text Key: 103803770
• Report Number: 3008452825-2018-00089
• 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
• Report Date: 03/26/2018

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: 10/31/2019
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 6223402
• Other Device ID Number: 05415067025715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• 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): Required Intervention