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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPRESS BRAIDED PERIPHERAL CATHETER; PERIPHERAL CATHETER,
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IMPRESS BRAIDED PERIPHERAL CATHETER; PERIPHERAL CATHETER, Back to Search Results
Model Number 00884450023181
Device Problems Fracture (1260); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/21/2020
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 aortic [aaa] [evar] repair the tip detached.The unit was used for a stent-graft procedure.After the use of the catheter, it was pulled out from the patient.However, the black tip immediately detached after withdrawal from the patient outside the body.No fragment remained in the patient.No patient injury.
 
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 PERIPHERAL CATHETER
Type of Device
PERIPHERAL CATHETER,
MDR Report Key10483305
MDR Text Key207829832
Report Number3010665433-2020-00033
Device Sequence Number1
Product Code DQO
UDI-Device Identifier00884450023181
UDI-Public00884450023181
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,foreig
Type of Report Initial,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/29/2023
Device Model Number00884450023181
Device Catalogue Number56538VER/JP
Device Lot NumberE1828902
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2020
Date Manufacturer Received11/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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