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U.S. Department of Health and Human Services

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

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AVINGER INC. PANTHERIS SV CATHETER, PERIPHERAL, ALTHERECTOMY, 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 Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/23/2019
Event Type  malfunction  
Event Description
During atherectomy of the tibial-peroneal trunk with the pantheris sv catheter, imaging was lost during advancement of the catheter. The physician noted that he had applied additional force just before imaging was lost. During retraction of the catheter, the nosecone detached from the cannula while the cannula and nosecone were within the sheath and both were withdrawn from the patient. No part of the device was left inside the patient. The sheath and guidewire did not have to be removed. The procedure continued with another pantheris sv device advanced through the sheath and was completed with no reports of patient injury or harm. The ifu for this device states as a precaution for the user to determine the cause of resistance to movement of the catheter before continuing to move the device against resistance.
 
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Brand NamePANTHERIS SV
Type of DeviceCATHETER, PERIPHERAL, ALTHERECTOMY, 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 Key9306209
MDR Text Key183163753
Report Number3007498664-2019-00004
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 10/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/19/2020
Device Model NumberA140-SV
Device Catalogue NumberA140-SV
Device Lot Number190919001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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