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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: R2P CROSSTELLA RX CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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R2P CROSSTELLA RX CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number BD-Q20040ER
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/01/2021
Event Type  malfunction  
Event Description
Peripheral balloon separated leaving a section of the catheter in the patient's artery which required retrieval.
 
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Brand NameR2P CROSSTELLA RX
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
MDR Report Key11436662
MDR Text Key238394431
Report Number11436662
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBD-Q20040ER
Device Catalogue NumberBD-Q20040ER
Device Lot NumberSR050293
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/03/2021
Event Location Hospital
Date Report to Manufacturer03/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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