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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 54038KA2
Device Problems Break (1069); Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2020
Event Type  malfunction  
Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that during an arteriogram procedure, the catheter tip partially detached within the patient.The physician had successfully acquired retrograde arterial access.Under fluoroscopy it was noted that contrast was coming out of the shaft where the rubber tip is fused.The partially detached catheter tip was successfully removed together with the guidewire.No patient injury to report.
 
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.
 
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Brand Name
IMPRESS®.BRAIDED CATHETER
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
MDR Report Key10896479
MDR Text Key218242075
Report Number3010665433-2020-00045
Device Sequence Number1
Product Code DQO
UDI-Device Identifier00884450032565
UDI-Public884450032565
Combination Product (y/n)N
PMA/PMN Number
K053171
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/16/2023
Device Catalogue Number54038KA2
Device Lot NumberE1937947
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Date Manufacturer Received04/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDEWIRE
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