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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAGONFLY¿ OPTIS¿ CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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DRAGONFLY¿ OPTIS¿ CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number C408645
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/25/2020
Event Type  Injury  
Event Description
An expired catheter was opened and used for a procedure.There were no adverse consequences to the patient.
 
Manufacturer Narrative
One dragonfly optis imaging catheter was received for evaluation.The results of the investigation concluded that the catheter had been kinked between the lens and the guidewire exit port.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the kinks is consistent with damage during use.
 
Event Description
Additional information was received that the device was not expired at the time of the procedure.
 
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Brand Name
DRAGONFLY¿ OPTIS¿ CATHETER
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
MDR Report Key11215288
MDR Text Key228215366
Report Number3009600098-2021-00004
Device Sequence Number1
Product Code DQO
UDI-Device Identifier00183739000647
UDI-Public00183739000647
Combination Product (y/n)N
PMA/PMN Number
K141453
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/03/2020
Device Model NumberC408645
Device Catalogue NumberC408645
Device Lot Number6703011
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2021
Was the Report Sent to FDA? No
Date Manufacturer Received01/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/05/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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