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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVINGER INC. PANTHERIS; CATHETER, PERIPHERAL, ATHERECTOMY
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AVINGER INC. PANTHERIS; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number A140-SV
Date of Event 10/08/2020
Type of Reportable Event Malfunction
Event or Problem Description
The pantheris sv catheter was advanced to the anterior tibial artery and atherectomy performed with no issues.The pantheris catheter was removed at the end of the procedure (the guidewire lumen was found torn/detached from the nosecone).As the physician attempted to remove the guidewire, which is not a product manufactured or distributed by avinger, inc., he met resistance.Using fluorocopy, it was noted that the guidewire was prolapsed on itself and the physician was unable to remove the guidewire.An arterial cutdown was performed and the guidewire was removed successfully.The patient was held overnight and released the next day.
 
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Brand Name
PANTHERIS
Common Device Name
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
AVINGER INC.
400 chesapeake drive
redwood city CA 94063
MDR Report Key10713257
Report Number3007498664-2020-00001
Device Sequence Number3814437
Product Code MCW
UDI-Device Identifier00851354004417
UDI-Public00851354004417
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K182341
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/08/2020
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Other
Device Expiration Date08/31/2021
Device Model NumberA140-SV
Device Catalogue NumberA140-SV
Device Lot Number190806002
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/08/2020
Initial Report FDA Received Date10/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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