MAUDE Adverse Event Report: CYTOPHIL, INC. RENÚ TRANSORAL NEEDLE; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number 12-000-00-ND1

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

The ucsf physician reported performing a challenging bedside peroral vocal fold injection of the patient's left vocal fold in the hospital where the patient's larynx moved significantly with each breath, making it difficult to maneuver the needle into an optimal position.During the final injection attempt, the physician reported not being able to place the tip of the needle into the vocal fold and no injection of the renú gel was performed at the patient's bedside.During this final attempt, the physician noted the 24 gauge needle did not seem to be connected to the shaft, and instead was laying horizontally at the base of the epiglottis perpendicular to the right ae fold.Although not in the lower airway, the needle had to be retrieved in the operating room (or).The injection of the renú gel was reported as being completed in the or and the patient was reported as being discharged.Ucsf physician reported both the shaft of the long 16 gauge injection needle and the smaller 24 gauge needle were bent for the procedure but no bends were made in the transitional area between the 16 and 24 gauge needles.The smaller gauge needle had a slight bend around the location of the black mark in the middle of the needle, 2nd mark from the tip.The physician noted the location where the needle broke was at the transition from the 16 gauge cannula to the 24 gauge needle.Within the renú gel ifu, being used with the renú tansoral needle, there is instruction to "not place pressure on the needle tip." in this event, the physician reported the 24 gauge needle was bent.Therefore, the renú transoral needle was used beyond its scope.Cytophil, inc.Requested that ucsf return the needle to cytophil, inc.For evaluation.The facility reported that it is against policy to return a device but would accommodate an onsite visit to examine the device.Cytophil has requested pictures of the device and is awaiting a response from the facility to confirm point of breakage.The needle lot information was not documented; and the needle packaging discarded.Cytophil, inc.Is attempting to identify the renú transoral through distribution records.Cytophil, inc.Is also in discussions with the finished transoral needle supplier, and with the 24 gauge needle component supplier to further investigate the potential cause of the needle failure.The 24 gauge needle component manufacturer noted no nonconformances in the manufacture of the material supplied to the transoral needle supplier.The transoral needle supplier reported no non-conformances, deviations, or abnormalities in the manufacturing records reviewed to date for needles supplied to cytophil, inc.The complaint investigation is on-going.A supplemental report will be provided.(ref.(b)(4)).

Event Description

The physician reported performing a challenging bedside peroral vocal fold injection of the patient left vocal fold in the hospital with renú gel lot q908-00087 and a renú transoral needle.The physician reported the patient's larynx moved significantly with each breath, making it difficult to maneuver the needle into an optimal position.Multiple attempts (reported to be approximately 3 to 4) at placing the needle were made going in and out of the patient's oral cavity and oropharynx with some contact with the mucosa of the palate, posterior pharyngeal wall, or base of tongue tissue being made, but never deeply, and superficial contact with the arytenoids.When trying to maneuver the needle into position on the last attempt, the physician noted the 24 gauge needle did not seem to be connected to the shaft, and instead was laying horizontally at the base of the epiglottis perpendicular to the right ae fold.The physician reported not being able to place the tip of the needle into the vocal fold and no injection of the renú gel was performed at the patient's bedside.Although not in the lower airway, the needle had to be retrieved in the or.The physician reported the injection of the renú gel was completed in the or.It was also reported that the needle packaging was discarded and the lot number not documented.Additionally, the physician reported both the shaft of the long 16 gauge injection needle and the smaller 24 gauge needle were bent for the procedure but no bends were made in the transitional area between the 16 and 24 gauge needles.The smaller gauge needle had a slight bend around the location of the black mark in the middle of the needle, 2nd mark from the tip.The physician noted the location where the needle broke was at the transition from the 16 gauge cannula to the 24 gauge needle.The needle lot information was not documented.The physician reported this is the first incident of needle breakage.(ref.(b)(4)).

Manufacturer Narrative

The 24 gauge needle manufacturer/supplier, the renú transoral needle contract manufacturer, and cytophil, inc.Performed investigation and device history record (dhr) reviews.No nonconformities or deviations were noted from the dhr reviews, the contract manufacturer confirmed no process or material changes occurred, and the 24 ga needle manufacturer/supplier confirmed there were no changes in material suppliers, design, or specifications.Device labeling was reviewed.Renú gel ifu rm 08-009 rev.01 provided with the renú gel product used during the procedure, has a note, "the ent needle shaft is malleable but has significant limitations.Do not place pressure on the needle tip." retain and return product evaluation noted no observations of underlying material issues impacting mechanical properties and concluded the failure was caused by plastic deformation (bending) of the stainless steel tube followed by overload failure; consistent with a force being applied to the 24 ga portion of the needle (by the physician) until failure.The physician is to be counseled on the limitations of bending of the needle and that care should be taken to apply pressure only to the 16 ga cannula portion of the needle and not the smaller 24 ga needle.Cytophil, inc.Has concluded its complaint investigation.The complaint is being closed and will be tracked and trended.(b)(4).

Manufacturer Narrative

1.The date referenced in b(4) "date of this report" field of supplemental report follow-up #2 was incorrect.The date entered should have been (b)(6) 2020 instead documented (b)(6) 2020.2.The event problem and evaluation codes h(6) method code(s): 4101 added.Testing of device from same lot/batch returned from user and 4103.Testing of device from lot/batch returned from user.3.The physician reported that pressure was applied to the smaller 24 gauge needle while bending the needle causing the breakage onf the 24 guage needle from the shaft.(ccr (b)(4)).

Manufacturer Narrative

The physician noted the location where the needle broke was at the transition from the 16 gauge cannula to the 24 gauge needle.Cytophil requested and received pictures of the device to determine point of breakage.Cytophil, inc.Cannot definitively confirm the reported point of breakage because only pictures of the 24 gauge portion of the needle were available.The facility is unable to definitively identify the specific needle lot number for the (b)(6) 2019 event, however a review of distribution records shows that needle lots q912-00031 and s912-00032 were shipped to the facility on october 01, 2019 through the same sales order.It can be reasonably concluded that one of these lots was used for the (b)(6) 2019 procedure.The complaint investigation is on-going.A supplemental report will be provided.(ref.(b)(4)).

• Brand Name: RENÚ TRANSORAL NEEDLE
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): CYTOPHIL, INC.; 2485 corporate circle; suite 2; east troy WI 53120
• MDR Report Key: 9377547
• MDR Text Key: 207737206
• Report Number: 3007225376-2019-00005
• Device Sequence Number: 1
• Product Code: GAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12-000-00-ND1
• Device Catalogue Number: 12-000-00-ND1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 60