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Model Number G35551
Device Problems Entrapment of Device (1212); Physical Resistance/Sticking (4012)
Patient Problems Stenosis (2263); Foreign Body In Patient (2687)
Event Date 12/06/2021
Event Type  malfunction  
Event Description
An elderly female with past medical history (pmh) of newly diagnosed diabetes mellitus (dm) and chronic hypertension with a two-day history of dizziness and weakness she had attributed to her new medications for dm, which made her leave work, go home, and lay down. At that point she experienced numbness and inability to move her right arm. She arrived in emergency room (er) one day (day 1) with these complaints although they had already resolved. Computerized tomography (ct) of head was negative for stroke, computed tomography angiography (cta) also negative. She was admitted for continued work-up by neurology and once again she experienced the numbness to the right face - magnetic resonance imaging (mri) showing acute left cerebellar infarct, microinfarct and chronic bilateral basal ganglia lacunar infarct. Symptoms once again completely resolved. She was taken to the cath lab and underwent a cerebral angiogram via radial artery access, two days after (day 3) the day she arrived in the er and finding were multifocal intracranial stenosis involving left mca, right mca as well as left intracranial vertebral artery. During the procedure it was noted that part of the micro-wire was stuck in soft tissue versus right radial artery near right radial puncture site and was not able to be removed. The radial access was then aborted, and groin access was obtained. Radial pulse was present and right ulnar artery was patent. Once the procedure was completed, vascular surgery was consulted, and she was taken to the or and underwent removal of foreign body and repair of right radial artery on day 4. Tolerated the procedure well, and once stable, was discharged home on day 5.
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Manufacturer (Section D)
750 daniels way
po box 489
bloomington IN 47402 0489
MDR Report Key14564213
MDR Text Key293103050
Report Number14564213
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG35551
Device Catalogue NumberMPIS-502-10.0-SC-NT-U-SST
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/17/2022
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer06/01/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown