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

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	07/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Target lesion was noted to be significantly calcified.Physician noted he used significant force in order to attempt to cross the lesion, however, given the lesion characteristics the catheter would not cross.At this point the lesion was pre-dilated with an angioplasty balloon.The catheter was then re-inserted and was able to cross without issue.It was noted that there was no oct image and possible fiber break.The device was then withdrawn into the sheath.The physician noted that he had to apply additional force at the iliac bifurcation to withdraw the device.At this point, the nosecone detached in the sheath and was contained within the sheath.The sheath was removed along with the nosecone which was contained within the sheath.No part of the device was left inside the patient.The guidewire did not have to be removed.A new sheath was inserted, and intervention continued with another device.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.

• Brand Name: PANTHERIS SV
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): AVINGER INC.; 400 chesapeake drive; redwood city CA 94063
• MDR Report Key: 8870791
• Report Number: 3007498664-2019-00002
• Device Sequence Number: 3079453
• 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): 07/29/2019

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: 10/01/2019
• Device Model Number: A140-SV
• Device Catalogue Number: A140-SV
• Device Lot Number: 190701001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/07/2019
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 71