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

Model Number C12058

Device Problems Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 05/26/2015

Event Type  Injury  

Event Description

The distal portion of a pressurewire aeris became stuck in a calcified lesion in the left anterior descending coronary artery.A non-sjm micro-catheter was used to remove the pressurewire from the patient.No breakage was observed upon removal.A second pressurewire aeris was used; however, it was unable to cross the lesion.The ffr procedure was aborted, and the patient is currently stable.

Manufacturer Narrative

(b)(4).The results of the investigation concluded the radiopaque tip had been stretched and kinked 2mm from the distal tip; there were also bends approximately 5mm and 8mm from the distal tip; the coated proximal tube had been kinked 671mm, 633mm, and 125mm from the proximal end.The kinked and stretched radiopaque tip is consistent with the reported maneuvering difficulties.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.The radiopaque tip damage and coated proximal tube damage is consistent with forcible contact during use.The pressurewire instructions for use (ifu) states that torquing the pressurewire against resistance or repeated attempts to cross a total vessel occlusion may cause damage and/or fracture.

• 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
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442
• MDR Report Key: 4855323
• MDR Text Key: 5874198
• Report Number: 3008452825-2015-00045
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2015

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: Other
• Device Expiration Date: 11/30/2016
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 4918699
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 06/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention