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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. CORSAIR PRO XS; MICROCATHETER
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ASAHI INTECC CO., LTD. CORSAIR PRO XS; MICROCATHETER Back to Search Results
Model Number CSR150-21S
Device Problems Break (1069); Separation Failure (2547)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/04/2020
Event Type  malfunction  
Event Description
While trying to penetrate this heavily calcified lad with an astato xs 20 guide wire with the support of the corsair pro xs microcatheter, the tip of the corsair pro xs broke off of the distal segment of the microcatheter and became affixed to the distal segment of the astato xs 20 guide wire.
 
Event Description
While trying to penetrate this heavily calcified lad with an astato xs 20 guide wire with the support of the corsair pro xs microcatheter, the tip of the corsair pro xs broke off of the distal segment of the microcatheter and became affixed to the distal segment of the astato xs 20 guide wire.
 
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Brand Name
CORSAIR PRO XS
Type of Device
MICROCATHETER
Manufacturer (Section D)
ASAHI INTECC CO., LTD.
3-100 akatsuki-cho
seto, aichi 489-0 071
JA  489-0071
MDR Report Key10428685
MDR Text Key203663338
Report Number3004718255-2020-00151
Device Sequence Number1
Product Code DQY
UDI-Device Identifier04547327123679
UDI-Public(01)04547327123679(17)221031(10)191122K041
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 08/19/2020,08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2022
Device Model NumberCSR150-21S
Device Catalogue NumberCSR150-21S
Device Lot Number191122K041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2020
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/19/2020
Distributor Facility Aware Date08/04/2020
Device Age10 MO
Event Location Hospital
Date Report to Manufacturer08/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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