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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MILLAR INC. TRANSDUCER, PRESSURE, CATHETER TIP
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MILLAR INC. TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number 825-0101 MILLAR PRESSURE CATHETER
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Atrial Fibrillation (1729); Paralysis (1997); Transient Ischemic Attack (2109)
Event Type  Injury  
Event Description
Post-procedure transient ischemic attack (tia).The serious adverse event most likely occured as a result of the pressure wire in the lv, no evidence of lbs lead perforation.Long procedure with episode of evidence of lbs lead perforation.Long procedure with episode of atrial fibrillation time onset symptoms: 18:30(90 mins post prcoedure) sudden minimal level of responsiveness with flaccid left hemiplegia, right fixed gaze conscious level fluctuated but paralysis persisted.No gross cn involvement initally - then developed deviation of pupils ~ 19s0hrs some improvement of l arm weakness but ongoing transferred to stroke unit, ct scan done: no acute bleed, no acute infarct detected aspirin 300mg stat followed by 7smg clopidogrel lifelong as per tia tx plan: 48hr repeat ct to see whether there have been any evidence of evolving stroke (b)(6) 2022 - symptoms fully resolved by approx.20:17hrs (b)(6) 2022 - patient feeling well inself, symptoms fully recovered.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
TRANSDUCER, PRESSURE, CATHETER TIP
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
MILLAR INC.
MDR Report Key17529504
MDR Text Key321143138
Report NumberMW5136430
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model Number825-0101 MILLAR PRESSURE CATHETER
Patient Sequence Number1
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