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

Model Number A200

Device Problems Difficult to Remove (1528); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2017

Event Type  malfunction  

Event Description

After successful atherectomy of a short focal lesion, 2 cm in length with 50% stenosis, upon attempting to withdraw the pantheris catheter, it met resistance.As the surgeon continued to pull against the resistance, he noticed that the catheter started to stretch, so he decided to remove the pantheris catheter, choice pt guidewire, and the terumo sheath together.The sheath, pantheris catheter, and choice pt guidewire were all removed successfully.After its removal, the pantheris catheter was examined and found to be damaged, but no components of the catheter were missing or detached.A second terumo sheath was inserted and a drug coated balloon was used to finish the procedure.Final run off was performed and the vessel was found to be patent.There were no patient complications, and follow-up with the physician revealed that the patient was doing well and was released from the hospital on schedule.

• Brand Name: PANTHERIS
• Type of Device: PERIPHERAL ATHERECTOMY CATHETER
• Manufacturer (Section D): AVINGER INC.; 400 chesapeake drive; redwood city CA 94063
• Manufacturer (Section G): AVINGER INC.; 400 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: bunty banerjee ; 400 chesapeake drive; redwood city, CA 94063 ; 6502417986
• MDR Report Key: 6569277
• MDR Text Key: 75345969
• Report Number: 3007498664-2017-00007
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/09/2017
• Device Model Number: A200
• Device Catalogue Number: A200
• Device Lot Number: 160309039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 154