MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA PRESSURE WIRE AERIS G8; TRANSDUCER, PRESSURE,CATHETER TIP

Model Number C12058

Device Problems Fracture (1260); Material Fragmentation (1261); Stretched (1601)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product evaluation the results of the investigation concluded that the tip coil of radiopaque tip and the hydrophilic coated distal tube had been bent.The tip coil of the radiopaque tip had been stretched just distal to the distal end of the jacket, which exposed the corewire.The corewire remained intact.The shaft had been kinked.There was no evidence found to suggest the incident was due to an intrinsic defect in the returned device.The device met specifications prior to leaving sjm manufacturing facilities as supported by a review of the device history record.Although the exact cause of the reported event remains unknown, the guidewire damage is consistent with the reported positioning issue.The cause of 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) states that the user should advance or withdraw the pressurewire slowly and never push, withdraw or torque the pressurewire if it meets resistance.

Event Description

When attempting to cross a lesion in the lad, the pressurewire aeris advanced in the diagonal unintentionally.Resistance was felt during advancements and pullbacks but then became stuck in the diagonal.The tip coil of the pressurewire aeris stretched and a snare was used to accompany the device during withdraw.When attempting to remove the device, the tip coil of the pressurewire aeris fractured inside the snare guide catheter.The entire pressurewire aeris was removed with no consequences to the patient.Ffr was aborted.

Manufacturer Narrative

Corrected information: the results of the investigation concluded that the tip coil of radiopaque tip and the hydrophilic coated distal tube had been bent.The tip coil of the radiopaque tip had been stretched just distal to the distal end of the jacket, which exposed the corewire.The corewire remained intact.No fracture was noted to the tip coil, inconsistent with the reported event description.The shaft had been kinked.There was no evidence found to suggest the incident was due to an intrinsic defect in the returned device.The device met specifications prior to leaving sjm manufacturing facilities as supported by a review of the device history record.Although the exact cause of the reported event remains unknown, the guidewire damage is consistent with the reported positioning issue.The cause of guidewire damage is consistent with forcible contact during use.

• Brand Name: PRESSURE WIRE AERIS G8
• 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: 5667943
• MDR Text Key: 45573104
• Report Number: 3008452825-2016-00065
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131452
• 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: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5348023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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