MAUDE Adverse Event Report: AVINGER INCORPORATED PANTHERIS; CATHETER

Model Number A200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 05/03/2016

Event Type  Injury  

Manufacturer Narrative

Device not returned, discarded by site.

Event Description

The physician informed an avinger sales representative that a patient who had an atherectomy procedure on (b)(6) 2016 using the pantheris catheter had complications resulting in the "need to perform surgeries".The physician informed the avinger representative that during the case, a spider filter wire (non-avinger device) was moving in a region distal to where the treatment occurred with the pantheris catheter.As a result of this movement, it was reported that the filter dissected the plaque and had created a blockage that required open surgery to fix.Furthermore, a groin complication was reported as a result of an unknown 7fr sheath (non-avinger device) that was used in the same procedure.No complications directly related to the pantheris catheter were reported by the physician.Follow up with the physician on (b)(6) 2016 revealed that the patient is still being treated in the hospital for wound problems.

• Brand Name: PANTHERIS
• Type of Device: CATHETER
• Manufacturer (Section D): AVINGER INCORPORATED; 400 chesapeake drive; redwood city 94063
• Manufacturer (Section G): AVINGER INCORPORATED; 400 chesapeake drive; redwood city 94063
• Manufacturer Contact: jennifer cleto ; 400 chesapeake drive; redwood city, CA 94063 ; 6502417900
• MDR Report Key: 5726856
• MDR Text Key: 47452205
• Report Number: 3007498664-2016-00007
• Device Sequence Number: 1
• Product Code: DQY
• 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: 06/15/2016

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
• Device Operator: Physician
• Device Expiration Date: 11/23/2016
• Device Model Number: A200
• Device Catalogue Number: A200
• Device Lot Number: 160323006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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
• Treatment: SPIDER 6.0 FILTER WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR