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

Model Number	A140-SV
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Event or Problem 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catheter, the nosecone detached from the cannula while the cannula and nosecone were within the sheath and both were withdrawn from the patient.No part of the device was left inside the patient.The sheath and guidewire did not have to be removed.The procedure continued with another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.

• Brand Name: PANTHERIS SV
• Common Device Name: CATHETER, PERIPHERAL, ALTHERECTOMY, PRODUCT CODE MCW
• Manufacturer (Section D): AVINGER INC.; 400 chesapeake drive; redwood city CA 94063
• MDR Report Key: 9306209
• Report Number: 3007498664-2019-00004
• Device Sequence Number: 1864440
• Product Code: MCW
• UDI-Device Identifier: 00851354004417
• UDI-Public: (01)00851354004417
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/19/2020
• Device Model Number: A140-SV
• Device Catalogue Number: A140-SV
• Device Lot Number: 190919001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 74