MAUDE Adverse Event Report: AVINGER INC. PANTHERIS; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	A140-SV
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
After 2 passes the guidewire became tangled in the device.When an attempt was made to remove the device it became tangled in the sheath.A retrograde access was obtained in the pta and a wire was advanced across the antegrade proximal sfa access site to control the site but the covered stent intended be deployed there could not be advanced past the area due to obstruction.A retrograde contralateral access was obtained and a sheath was placed up and over the iliac bifurcation to control from above.Sheath wires and device were removed with difficulty from initial access site and a covered stent was placed.Patient was admitted to the hospital for observation and was discharged the next day without any treatment administered.
Event or Problem Description
After 2 passes the guidewire became tangled in the device.When an attempt was made to remove the device it became tangled in the sheath.A retrograde access was obtained in the pta and a wire was advanced across the antegrade proximal sfa access site to control the site but the covered stent intended be deployed there could not be advanced past the area due to obstruction.A retrograde contralateral access was obtained and a sheath was placed up and over the iliac bifurcation to control from above.Sheath wires and device were removed with difficulty from initial access site and a covered stent was placed.Patient was admitted to the hospital for observation and was discharged the next day without any treatment administered.

• Brand Name: PANTHERIS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): AVINGER INC.; 400 chesapeake drive; redwood city CA 94063
• MDR Report Key: 12019686
• Report Number: 3007498664-2021-00002
• Device Sequence Number: 17194758
• Product Code: MCW
• UDI-Device Identifier: 00851354004417
• UDI-Public: 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 04/08/2023
• Device Model Number: A140-SV
• Device Catalogue Number: A140-SV
• Device Lot Number: 210408002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 86 YR
• Patient Weight: 93