MAUDE Adverse Event Report: ST. JUDE MEDICAL PRESSUREWIRE AERIS AGILE TIP (GUIDEWIRE MOUNTED SENSOR); TRANSDUCER, PRESSURE, CATHETER TIP

Catalog Number C12058

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2016

Event Type  malfunction  

Event Description

Patient was taken urgently to the cardiac cath lab for a coronary angiogram.Using the appropriate guiding catheter, a doppler flow wire was inserted across the mid left anterior descending (lad) artery lesion and pressures were recorded.The tip of the doppler flow wire broke off in the distal lad and was retrieved and removed with a microsnare kit.Pigtail catheter was inserted through the sheath and into the ascending aorta and left ventricle.Left heart cath and left ventriculogram were performed without complication.No patient harm occurred.Patient was discharged to home the day after the procedure in good condition.Broken device will be given to st.Jude medical representative by cardiac cath lab manager.

• Brand Name: PRESSUREWIRE AERIS AGILE TIP (GUIDEWIRE MOUNTED SENSOR)
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 5528698
• MDR Text Key: 41233178
• Report Number: 5528698
• 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: Other
• Type of Report: Initial
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: C12058
• Device Lot Number: 5282657
• 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: 03/18/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2016
• 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
• Patient Age: 53 YR
• Patient Weight: 90