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

Model Number AERIS¿ AGILE TIP

Device Problems Break (1069); Kinked (1339); Failure to Advance (2524)

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

Event Date 11/21/2016

Event Type  malfunction  

Event Description

Patient was undergoing stenting of the right coronary artery (rca).The rca lesion was wired using a fractional flow reserve wire (ffr).A drug eluting stent was then deployed.Upon removing the stent balloon, the balloon caught on the wire resulting in severe kinking of the wire and also caused the wire to pull back across the lesion.The rca was rewired and an attempt was made to advance another stent to the mid rca, but the wire broke and the stent caught as it was entering the guiding catheter.The wire was removed and the vessel was rewired using a different coronary wire.Timi 3 flow was demonstrated throughout.

• 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: 6263479
• MDR Text Key: 65258447
• Report Number: 6263479
• 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: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: AERIS¿ AGILE TIP
• Device Catalogue Number: C12058
• Device Lot Number: 5615302
• Other Device ID Number: ST JUDE AERIS 175 PRESSURE WI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC CORPORATION SYNERGY 2.25MM 120MM; NO OTHER THERAPIES
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 102