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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
Model Number 512538MPA1
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/09/2019
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 balloon-occluded retrograde transvenous obliteration (brto) procedure, for the treatment of gastric varices, the diagnostic catheter tip detached.No medical or surgical intervention was necessary for removal of the detached tip.The tip remained on the guidewire and was removed together from the patient.No additional consequences to report.
 
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Brand Name
IMPRESS®.BRAIDED.CATHETER
Common Device Name
PERIPHERAL CATHETERS
MDR Report Key12363246
Report Number3010665423-2021-00068
Device Sequence Number12044879
Product Code DQO
UDI-Device Identifier00884450035894
UDI-Public884450035894
Combination Product (Y/N)N
Initial Reporter CountryIN
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,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/30/2022
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 Date04/30/2022
Device Model Number512538MPA1
Device Lot NumberE1565018
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/19/2021
Initial Report FDA Received Date08/24/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured05/09/2019
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
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