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

Model Number A400

Device Problems Device Damaged by Another Device (2915); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problems Peripheral Vascular Disease (2002); Vascular Dissection (3160)

Event Date 09/06/2018

Event Type  Injury  

Event Description

During an atherectomy of the superficial femory artery, it was reported that the guidewire being used with the pantheris catheter kinked and the device resisted removal.The physician eventually was able to remove the catheter, guidewire, and vascular sheath successfully from the patient, but it was observed that a vessel dissection occurred at the access side.The dissection was resolved surgically, and the patient was released from the hospital the following day without any complications.Vessel dissection is listed in the ifu as a potential adverse event associated with use of the pantheris system and other interventional catheters.

• Brand Name: PANTHERIS
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): AVINGER INC.; 400 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: jay sundaram ; 400 chesapeake drive; redwood city, CA 94063
• MDR Report Key: 7882383
• MDR Text Key: 120458369
• Report Number: 3007498664-2018-00003
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 07/10/2019
• Device Model Number: A400
• Device Catalogue Number: A400
• Device Lot Number: 180710009
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: .014" GUIDEWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 67