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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPRESS®.BRAIDED CATHETER; PERIPHERAL CATHETERS
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IMPRESS®.BRAIDED CATHETER; PERIPHERAL CATHETERS Back to Search Results
Catalog Number 54038KA2
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/21/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event or Problem Description
The account alleges that during a vascular procedure, the tip of the catheter broke and almost detached within the patient during the procedure.The device was removed from the patient with no injury to report.
 
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Corrective actions are in process.
 
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Brand Name
IMPRESS®.BRAIDED CATHETER
Common Device Name
PERIPHERAL CATHETERS
MDR Report Key12139983
Report Number3010665433-2021-00050
Device Sequence Number4898401
Product Code DQO
UDI-Device Identifier00884450032565
UDI-Public884450032565
Combination Product (Y/N)N
Initial Reporter StateTX
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) 06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date06/20/2024
Device Catalogue Number54038KA2
Device Lot NumberE2097461
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2021
Initial Date Received by Manufacturer 06/21/2021
Supplement Date Received by Manufacturer07/22/2021
Initial Report FDA Received Date07/08/2021
Supplement Report FDA Received Date07/28/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured05/06/2021
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
Concomitant Medical Products
and Therapy/Usage Dates
GUIDEWIRE.
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