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

Model Number C12058

Device Problems Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The pressurewire aeris ii guidewire was returned to the sjm postmarket surveillance laboratory for analysis.The transmitter was not returned.Visual inspection of the guidewire revealed the coated proximal tube had been bent 935mm from the proximal end.No other visual anomalies were noted.The guidewire was inserted and advanced through coronary artery simulator and withdrawn without difficulty or resistance.No functional anomalies were noted.The results of the investigation concluded that the coated proximal tube had been bent.The damage to the guidewire suggested a possible cause for the reported insertion difficulty; however, the guidewire was inserted and advanced through coronary artery simulator and withdrawn without difficulty or resistance.There was no evidence found to suggest the incident was due to an intrinsic defect in the returned device.The device met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.The cause of the reported event 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.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.

Event Description

Resistance was felt when the pressurewire aeris was advanced into the distal rca with severe tortuosity.It was reported there was a sound like a wire snapped that was heard at the proximal end of the wire.The tip of the pressurewire would not move when the pressurewire was pulled back.The pressurewire and guiding catheter were removed from the patient using an additional catheter with a balloon.It was reported the pressurewire was intact with no remarkable damage visible.The ffr measurement was aborted.

• 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: 5256226
• MDR Text Key: 32344930
• Report Number: 3008452825-2015-00111
• 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
• Report Date: 11/04/2015

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: 05/31/2017
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5144312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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