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

Model Number C12058

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Physical Resistance (2578)

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

Event Type  Injury  

Event Description

After a pressurewire aeris was flushed, resistance was felt while withdrawing the wire from its packaging.During the second ffr measurement, the pressurewire aeris became stuck in a vessel and could not be removed.A balloon was used to help remove the pressurewire aeris.The procedure was completed with another pressurewire aeris.

Manufacturer Narrative

(b)(4).The results of the investigation concluded that the radiopaque tip coil was bent in an ¿s¿ shaped curve; the proximal end of the tip coil had been stretched approximately 2mm in length; the core wire and the tip coil remained intact.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 the device history record.Although the exact cause of the reported withdrawal difficulties remains unknown, both the reported resistance during withdrawal of the device from its packaging, and the reported device becoming stuck during use, are consistent with the damage to the tip coil.How or when the tip coil damage occurred remains unknown.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.

• 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 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 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 5085567
• MDR Text Key: 26102458
• Report Number: 3008452825-2015-00075
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Followup
• Report Date: 08/27/2015

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: 03/31/2017
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5063135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2015
• 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