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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. PRESSUREWIRE AERIS AGILE TIP; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
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ST. JUDE MEDICAL, INC. PRESSUREWIRE AERIS AGILE TIP; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY Back to Search Results
Model Number AERIS¿ AGILE TIP
Device Problem Failure to Advance (2524)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/02/2016
Event Type  Injury  
Event Description
Patient was undergoing an elective percutaneous coronary intervention.The mid-lad had intermediate stenosis in the mid-portion of the vessel.For measurement of flow, an ffr wire was advanced through the guide sheath to the mid-lad; however, due to the patient's coronary anatomy, difficulty accessing desired location in the mid-lad occurred.The ffr wire was repeatedly withdrawn by the physician to be physically manipulated and redirected to reach the designated location of the mid-lad.After repeated attempts, the ffr wire was withdrawn, leaving the distal portion of the wire retained in the mid-lad.Based on consultation with the physician and the rep, we estimate that approximately 3 cm of the wire remained in the patient's vessel.The st.Jude representative was given the remaining portion of the ffr device so that the manufacturer could evaluate the product.The sales rep informed us that he would be sending a report to the manufacturer's risk management team.The rep removed the remaining ffr wires from the same lot number and provided us with replacements of another lot number.Manufacturer response for pressure wire aeris agile tip, pressure wire aeris (per site reporter): the st.Jude representative was given the remaining portion of the ffr device so that the manufacturer could evaluate the product.The sales rep informed us that he would be sending a report to the manufacturer's risk management team.The rep removed the remaining ffr wires from the same lot number and provided us with replacements of another lot number.
 
Event Description
Patient was undergoing an elective percutaneous coronary intervention.The mid-lad had intermediate stenosis in the mid-portion of the vessel.For measurement of flow, an ffr wire was advanced through the guide sheath to the mid-lad; however, due to the patient's coronary anatomy, difficulty accessing desired location in the mid-lad occurred.The ffr wire was repeatedly withdrawn by the physician to be physically manipulated and redirected to reach the designated location of the mid-lad.After repeated attempts, the ffr wire was withdrawn, leaving the distal portion of the wire retained in the mid-lad.Based on consultation with the physician and the rep, we estimate that approximately 3 cm of the wire remained in the patient's vessel.The st.Jude representative was given the remaining portion of the ffr device so that the manufacturer could evaluate the product.The sales rep informed us that he would be sending a report to the manufacturer's risk management team.The rep removed the remaining ffr wires from the same lot number and provided us with replacements of another lot number.Manufacturer response for pressure wire aeris agile tip, pressure wire aeris (per site reporter): the st.Jude representative was given the remaining portion of the ffr device so that the manufacturer could evaluate the product.The sales rep informed us that he would be sending a report to the manufacturer's risk management team.The rep removed the remaining ffr wires from the same lot number and provided us with replacements of another lot number.
 
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Brand Name
PRESSUREWIRE AERIS AGILE TIP
Type of Device
TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
5050 nathan lane north
plymouth MN 55442
MDR Report Key6248915
MDR Text Key64738008
Report Number6248915
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Physician
Device Expiration Date03/31/2018
Device Model NumberAERIS¿ AGILE TIP
Device Catalogue NumberC12058
Device Lot Number5488346
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/12/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer01/12/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/13/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/13/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
FFR WAS INSERTED THROUGH AN INTRODUCER SHEATH, A 6; FFR WAS INSERTED THROUGH AN INTRODUCER SHEATH, A 6; NO OTHER THERAPIES; NO OTHER THERAPIES
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age51 YR
Patient Weight99
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