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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
Device Problems Failure to Unfold or Unwrap (1669); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 10/08/2020
Event Type  malfunction  
Event 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 NamePANTHERIS
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
AVINGER INC.
400 chesapeake drive
redwood city CA 94063
Manufacturer Contact
jay sundaram
400 chesapeake drive
redwood city, CA 94063
MDR Report Key10713257
MDR Text Key249817223
Report Number3007498664-2020-00001
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date08/31/2021
Device Model NumberA140-SV
Device Catalogue NumberA140-SV
Device Lot Number190806002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/14/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/21/2020 Patient Sequence Number: 1
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