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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPRESS®.BRAIDED.; PERIPHERAL CATHETERS
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IMPRESS®.BRAIDED.; PERIPHERAL CATHETERS Back to Search Results
Catalog Number 46535BER
Medical Device Problem Codes Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/05/2020
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 the tip of the catheter detached during a procedure and was seen during an intra-op x-ray.The tip was successfully retrieved and a final x-ray was performed to confirm complete removal of the piece.No additional patient consequences to report.
 
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Brand Name
IMPRESS®.BRAIDED.
Common Device Name
PERIPHERAL CATHETERS
MDR Report Key12051017
Report Number3010665433-2021-00047
Device Sequence Number3427311
Product Code DQO
UDI-Device Identifier00884450020135
UDI-Public884450020135
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K053171
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/16/2021
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? Yes
Operator of Device Health Professional
Device Catalogue Number46535BER
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/16/2021
Initial Report FDA Received Date06/23/2021
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
Concomitant Medical Products
and Therapy/Usage Dates
GUIDEWIRE
Outcome Attributed to Adverse Event Required Intervention;
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