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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCUCATH CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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ACCUCATH CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/24/2021
Event Type  malfunction  
Event Description
Patient brought to interventional radiology suite for midline catheter placement. On pre-procedure ultrasound of the right upper extremity for vein assessment, a retained intravascular microwire was seen. This was confirmed by fluoroscopy. Upon review of the medical record, the interventional radiology team could not find that it was ever that a retained foreign body was recorded. Per history obtained from the patient, the patient stated that, there was an attempt to by 2 nurses to place an ultrasound-guided iv at bedside. An iv was placed but it never worked well and was eventually removed prior to the patient coming to ir. Review of the electronic medical record by the interventional radiology team was performed; documentation of this event was unable to be found. It seems the accucath wire fractured.
 
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Brand NameACCUCATH
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12459495
MDR Text Key271041144
Report Number12459495
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/31/2021
Event Location Hospital
Date Report to Manufacturer09/13/2021
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 Unkown

Patient Treatment Data
Date Received: 09/13/2021 Patient Sequence Number: 1
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