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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. PRESSUREWIRE TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

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ST. JUDE MEDICAL, INC. PRESSUREWIRE TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY Back to Search Results
Catalog Number C12058
Device Problems Material Frayed (1262); Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/21/2016
Event Type  malfunction  
Event Description
An euphora balloon was attempted to be inserted over the fractional flow reserve (ffr) wire with inability to advance the balloon. When provider pulled back on ffr wire, he noted fraying of the wire. This portion of the wire was external to the patient. But the provider did not continue use of the wire due to the fray. Provider used a different wire and procedure was completed without issue. There was not patient harm to that occurred. Manufacturer response for pressure wire, pressure wire aeris agile tip (per site reporter). The st. Jude representative replaced our lot and that he would follow up with his reporting process.
 
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Brand NamePRESSUREWIRE
Type of DeviceTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
5050 nathan lane north
plymouth MN 55442
MDR Report Key6379931
MDR Text Key69119997
Report Number6379931
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
Type of Report Initial
Report Date 02/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2017
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberC12058
Device Lot Number5707689
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/14/2017
Device Age2 MO
Event Location Hospital
Date Report to Manufacturer02/14/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/06/2017 Patient Sequence Number: 1
Treatment
NOT APPLICABLE.; POTENTIALLY THE ATTEMPT TO ADVANCE EUPHORA BALLOON
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