MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. PRESSUREWIRE; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number AERIS¿ AGILE TIP

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Device Dislodged or Dislocated (2923)

Patient Problems Tissue Damage (2104); Vascular Dissection (3160)

Event Date 07/10/2017

Event Type  malfunction  

Event Description

Patient was undergoing coronary intervention (ffr) of obtuse marginal vessel of the left circumflex coronary artery using aeris pressure wire.During advancement into om1, usual negotiation of the ffr wire through distal curvature resulted in wire becoming non-responsive.Wire carefully counter-rotated to remove but still would not respond normally.Ultimately wire tip fragmented and was loose in om1.Two soft wires looped around wire fragment which was atraumatically brought into the left main.While preparing to snare, wire embolized to the abdominal aorta and appeared to lodge in a lumbar artery.Retrieval was attempted but the wire fragment migrated more distally into lumbar artery.Attempt to snare unsuccessful and resulted in dissection in lumbar artery with symptoms requiring ptca to restore flow.Three wires were then passed distal to wire fragment and was able to engage and retrieve the wire into the guide.The entire wire-device-guide unit was pulled out under fluoroscopy with confirmed full retrieval of the ffr wire.

• Brand Name: PRESSUREWIRE
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 6716686
• MDR Text Key: 80131352
• Report Number: 6716686
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2018
• Device Model Number: AERIS¿ AGILE TIP
• Device Catalogue Number: C12058
• Device Lot Number: 5747399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 101