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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVINGER INC. PANTHERIS CATHETER, PERIPHERAL, ATHERECTOMY, PRODUCT CODE: MCW

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AVINGER INC. PANTHERIS CATHETER, PERIPHERAL, ATHERECTOMY, PRODUCT CODE: MCW Back to Search Results
Model Number A400X
Device Problems Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)
Patient Problem Peripheral Vascular Disease (2002)
Event Date 11/14/2019
Event Type  malfunction  
Event Description
During atherectomy in the popliteal artery, the pantheris catheter contacted an indwelling vascular stent and resisted retraction. The physician gained pedal access, advanced a balloon retrograde and performed angioplasty to free the catheter from the stent. The procedure was completed with no patient injury reported. The device was successfully retrieved, and no missing or detached components of the device were confirmed. The ifu of the pantheris device instructs users how to identify the struts of an indwelling vascular stent using the real-time oct imaging component of the pantheris system in order to avoid such contact.
 
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Brand NamePANTHERIS
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY, PRODUCT CODE: MCW
Manufacturer (Section D)
AVINGER INC.
400 chesapeake drive
redwood city CA 94063
Manufacturer Contact
jay sundaram
400 chesapeake drive
redwood city, CA 94063
6502417900
MDR Report Key9418309
MDR Text Key183163475
Report Number3007498664-2019-00005
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173862
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 11/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date09/10/2021
Device Model NumberA400X
Device Catalogue NumberA400X
Device Lot Number191002005
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2019
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: 12/05/2019 Patient Sequence Number: 1
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