MAUDE Adverse Event Report: ST. JUDE MEDICAL PRESSUREWIRE AERIS AGILE TIP; FFR PRESSURE WIRE

Catalog Number C12358

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/03/2016

Event Type  Injury  

Event Description

We were doing coronary angiogram and found that pt had proximal lad lesion.We decided to do ffr for the lesion to assess the severity.We inserted pressurewire aeris agile tip ((b)(4) medical).Within a few seconds of manipulation.It was noted the front 5cms of the wire was not attached to the rest of the system and was floating in lad.We spent a couple hours and were successful in retrieving the broken wire.

• Brand Name: PRESSUREWIRE AERIS AGILE TIP
• Type of Device: FFR PRESSURE WIRE
• Manufacturer (Section D): ST. JUDE MEDICAL; plymouth MN 55442
• MDR Report Key: 6147560
• MDR Text Key: 61625540
• Report Number: MW5066548
• Device Sequence Number: 1
• Product Code: DXO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2018
• Device Catalogue Number: C12358
• Device Lot Number: 5555469
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 77