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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO MIDLINE MIDLINE CATHETER,,

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ANGIODYNAMICS BIOFLO MIDLINE MIDLINE CATHETER,, Back to Search Results
Catalog Number 46490
Device Problems Difficult to Remove (1528); Use of Device Problem (1670)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/17/2021
Event Type  Injury  
Manufacturer Narrative
It was reported that the device is not available to be returned to the manufacturer for evaluation. The results of the investigation will be sent via a follow up medwatch. (b)(4).
 
Event Description
An ir director reported an issue with a bioflo midline 5f dl-20cm max sterile barrier drape kit w/ two nitinol guidewires. During the placement procedure, the guidewire got stuck in the patient's vessel. Two different ir physician's attempted to remove the guidewire and were unsuccessful. At the time of notification, the patient was currently scheduled to go to surgery to get the guidewire removed from the vessel. Additional information reported the patient underwent vascular surgery at which time they were able to successfully remove the guidewire. When they did the vascular removal, the physician used the same insertion site on the right side of the arm as the ir physician and the gw was right there in the vessel of the arm and was retrieved. The x-ray shows the entire length of the gw goes from the insertion site all the way to the heart. It's a long wire. The midline catheter itself was never inserted. It was indicated that the reported device is not available to be returned to the manufacturer for evaluation. There was no report of permanent patient harm or injury.
 
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Brand NameBIOFLO MIDLINE
Type of DeviceMIDLINE CATHETER,,
Manufacturer (Section D)
ANGIODYNAMICS
10 glens falls technical park
glens falls, ny 12801 NY 12801
Manufacturer (Section G)
ANGIODYNAMICS
10 glens falls technical park
glens falls, ny 12801 NY 12801
Manufacturer Contact
alexandra invencio
26 forest street
marlborough, MA 01752
5086587805
MDR Report Key11621951
MDR Text Key244027094
Report Number1317056-2021-00073
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161866
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Catalogue Number46490
Device Lot Number5634755
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/02/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/06/2021 Patient Sequence Number: 1
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