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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO MEDICAL CORP / KANEKA CORPORATION OSAKA PLANT TERUMO R2P METACROSS RX CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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TERUMO MEDICAL CORP / KANEKA CORPORATION OSAKA PLANT TERUMO R2P METACROSS RX CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number BD-P30200ER
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/28/2020
Event Type  Injury  
Event Description
Terumo r2-p metacross rx pta balloon dilatation catheter separated and unsheathed leaving the balloon in the aorta/iliac artery during peripheral angiogram; patient required transport to a higher level of care for retrieval.
 
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Brand NameTERUMO R2P METACROSS RX
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
TERUMO MEDICAL CORP / KANEKA CORPORATION OSAKA PLANT
MDR Report Key11139290
MDR Text Key226276042
Report NumberMW5098740
Device Sequence Number1
Product Code LIT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2022
Device Model NumberBD-P30200ER
Device Catalogue NumberBD-P30200ER
Device Lot NumberSP029238
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/07/2021 Patient Sequence Number: 1
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