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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. IMPRESS BRAIDED PERIPHERAL CATHETER
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MERIT MEDICAL SYSTEMS, INC. IMPRESS BRAIDED PERIPHERAL CATHETER Back to Search Results
Model Number 00884450026571
Device Problems Fracture (1260); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/15/2020
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 iliac angioplasty, after crossing the long iliac calcified occlusion, on removal of the catheter the distal segment fractured and was retained within the patient.The segment was successfully retrieved and no harm has come to the patient.
 
Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.No definitive root cause could be determined however, it is likely that significant force was applied to the device during use.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
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
14646 kirby drive
houston, tx
MDR Report Key10317266
MDR Text Key207829246
Report Number3010665433-2020-00025
Device Sequence Number1
Product Code DQO
UDI-Device Identifier00884450026571
UDI-Public00884450026571
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 07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Model Number00884450026571
Device Catalogue Number46538BER
Device Lot NumberE1735887
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2020
Date Manufacturer Received08/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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