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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPRESS®.BRAIDED CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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IMPRESS®.BRAIDED CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number 59038UAC
Medical Device Problem Codes Material Fragmentation (1261); Material Deformation (2976)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/09/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
 
Event or Problem Description
The account alleges that during a fibroid embolization the physician torqued the catheter to the point it became severely twisted.In an attempt to untwist, a stiff guide wire was inserted to straighten the catheter.Without checking to make sure the catheter was straight, the catheter was pulled aggressively and detached in the distal end of the patient.The detached piece was successfully collected with a snare.No patient harm to report.
 
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned at a later date, the investigation will be re-opened.
 
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Brand Name
IMPRESS®.BRAIDED CATHETER
Common Device Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
MDR Report Key12046713
Report Number3010665433-2021-00045
Device Sequence Number19978715
Product Code DQO
UDI-Device Identifier00884450109373
UDI-Public884450109373
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K053171
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number59038UAC
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/09/2021
Supplement Date Received by Manufacturer08/16/2021
Initial Report FDA Received Date06/22/2021
Supplement Report FDA Received Date08/18/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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