MAUDE Adverse Event Report: CYTOPHIL, INC. RENÚ VOICE, 1.5CC; SYSTEM, VOCAL CORD MEDIALIZATION

Model Number	08-015-04-V04
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cytophil requested and received additional information regarding the event and the patient's current status.Regarding the event, the physician's office reported that the crack occurred at the "hub of the syringe, where the needle attaches." following the procedure, the patient returned for a follow up appointment on (b)(6) 2017.During that office visit, the physician reported that there was "arthyenoid movement bilateral; still with persistent glottis gap." the physician recommended that the patient seek a second opinion.The patient is scheduled to return for a follow up appointment on (b)(6) 2017.Cytophil requested and received the device for evaluation.The device was returned to cytophil, and was evaluated "as received" under 50x magnification.It was then carefully rinsed and viewed again under 50x magnification.There was no visible defect viewed under magnification.The syringe was then filled with water as a worst case test, and tested under pressure, with no leakage occurring.The device performed according to specification and was determined to have not cracked, as reported.Cytophil did not receive the needle for evaluation.A review of the device history records did not reveal any irregularities or issues with syringes.Cytophil will provide a supplemental report after the patient's (b)(6) 2017 appointment.
Event or Problem Description
During a renu voice procedure, the physician performed an initial injection of the renu voice material into the patient's vocal fold without any reported issue.It was reported by the physician's nurse manager that the physician then attempted to inject additional material from this same syringe, and the syringe "cracked." it was also reported that the syringe did not then contain enough material to complete the patient's procedure.Since the physician's office did not have an additional renu voice devices available for use during the patient's procedure, the nurse manager "believes" that the patient was offered the opportunity to continue and complete the procedure at the hospital where additional renu voice products were available for use, however the patient declined to complete the procedure at the hospital.
Additional Manufacturer Narrative
The patient was scheduled to return to the physician's office for a follow up visit on (b)(6) 2017.The patient did not return for this appointment.The physician's office reported that the patient did obtain a second opinion, however they have no information as to what the patient's plan is going forward.The results of cytophil's complaint investigation are inconclusive.Cytophil was unable to confirm the reported complaint, or to definitively identify a root cause of the reported event.The syringe barrel with the luer fitting engaged performed according to specification.It can be reasonably hypothesized that the user may have slightly backed off the luer connection as part of maneuvering during the injection, which could have resulted in slight leakage.A review of cytophil's complaint history for the past 24 months indicates one similar complaint.The complaint is being closed, and will be tracked.

• Brand Name: RENÚ VOICE, 1.5CC
• Common Device Name: SYSTEM, VOCAL CORD MEDIALIZATION
• Manufacturer (Section D): CYTOPHIL, INC.; 2485 corporate circle; suite 2; east troy WI 53120
• MDR Report Key: 6925638
• Report Number: 3007225376-2017-00004
• Device Sequence Number: 13781190
• Product Code: MIX
• UDI-Device Identifier: 00856509002294
• UDI-Public: (01)00856509002294(10)Q708-00031(17)190418
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K121795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2017

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: Physician
• Device Expiration Date: 04/18/2019
• Device Model Number: 08-015-04-V04
• Device Lot Number: Q708-00031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 85