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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 565352RC
Medical Device Problem Codes Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/20/2020
Type of Reportable Event Serious Injury
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 uterine artery embolization [uae] procedure, the catheter tip detached within the patient.The physician had acquired retrograde arterial access and during catheter manipulations under fluoroscopy, over a guide wire the catheter tip detached.The physician successfully retrieved the foreign body from the patient.The patient tolerated the procedure well and was discharged to home with no additional consequences to report.
 
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned at a later date, the investigation will be re-opened.
 
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Brand Name
IMPRESS®.BRAIDED CATHETER
Common Device Name
PERIPHERAL CATHETERS
MDR Report Key11013379
Report Number3010665433-2020-00056
Device Sequence Number2684759
Product Code DQO
UDI-Device Identifier00884450009376
UDI-Public884450009376
Combination Product (Y/N)N
Initial Reporter CountryFR
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,Followup
Report Date (Section B) 11/26/2020
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 Expiration Date08/31/2021
Device Catalogue Number565352RC
Device Lot NumberE1419507
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/26/2020
Supplement Date Received by Manufacturer02/23/2021
Initial Report FDA Received Date12/15/2020
Supplement Report FDA Received Date03/03/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured09/25/2018
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
GUIDE WIRE; GUIDE WIRE
Outcome Attributed to Adverse Event Required Intervention;
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