SENTINELLE ARRAY BREAST COIL
Received Jan 16, 2016 · Event occurred Jan 4, 2016
Report MW5059480 · MDR key 5383821
Device
Generic name
Sentinelle Array Breast Coil
Manufacturer
Sintinelle VanguardModel number
SENTINELLE VANGUARD BREAST COILProduct problems
- Failure of Device to Self-Test
Patient
74 YR
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
SIEMENS MAGNETOM ESPREE 1.5T MRI SCANNER WITH THE SENTINELLE VANGUARD BREAST COIL; (FOR SIEMENS BREAST MRI AUXILIARY TABLE WITH 2/4/8- CHANNEL COIL ARRAY BREAST COIL) WAS UTILIZED ON PATIENT FOR MRI OF THE BREAST. THE PATIENT REPORTED RIGHT SIDED BURNING OF THE RIGHT FLANK REGION IMMEDIATELY AFTER THE MRI EXAM. UPON ASSESSMENT BY THE TECHNOLOGIST, REDNESS WAS OBSERVED IN THE REPORTED AREA BY THE PATIENT. THE NEXT DAY, THE PATIENT WAS EVALUATED AND TREATED BY HER PHYSICIAN FOR BLISTERING ON RIGHT SIDE OF HER ABDOMEN AND HER RIGHT FOREARM. CONTRIBUTING FACTORS; RF POWER WAS BEING TRANSMITTED BY THE BODY COIL; AND THE TRANSMITTED RF POWER WAS BEING TRANSMITTED TO A VOLUME/ANATOMY THAT DID INCLUDE THE ABDOMEN AND FOREARM. SUSPECT PATIENT'S FOREARM AND ABDOMEN WERE TOUCHING, (AND RIGHT AT THE LEVEL OF THE THERMAL INJURY), DURING THE EXAMINATION. THE ELECTRICAL CONDUCTIVITY OF POSSIBLE PERSPIRATION MIGHT WELL HAVE BEEN RELATED TO THE OBSERVED OUTCOME. THERE WERE NO UNUSUAL FACTORS NOTED, NO EXCESSIVE SWEATING WAS OBSERVED. THE COIL WAS REMOVED FROM SERVICE AND WILL BE SENT BACK TO MANUFACTURER FOR FAILURE MODE TESTING.