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U.S. Department of Health and Human Services

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

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AVINGER INC. PANTHERIS SV CATHETER, PERIPHERAL, ATHERECTOMY, PRODUCT CODE: MCW Back to Search Results
Model Number A140-SV
Device Problems Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2019
Event Type  malfunction  
Event Description
During an atherectomy of the posterior tibial and peroneal artery, the guidewire lumen separated from the nosecone while advancing the device against resistance. The guidewire lumen was found on the guidewire when the device and guidewire were removed in its entirety from the patient. The procedure was completed with no reports of patient injury or harm. The ifu for this device states a precaution to determine the cause of resistance to movement of the catheter before proceeding with manipulation of the device.
 
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Brand NamePANTHERIS SV
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 Key9234834
MDR Text Key183166343
Report Number3007498664-2019-00003
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 10/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/04/2020
Device Model NumberA140-SV
Device Catalogue NumberA140-SV
Device Lot Number190904001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/13/2019
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: 10/24/2019 Patient Sequence Number: 1
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