MAUDE Adverse Event Report: AIRGAS THERAPEUTICS LLC ISPAN SULFUR HEXAFLUORIDE (SF6) GAS; INTRAOCULAR GAS

Catalog Number	8065797005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Visual Impairment (2138); Loss of Vision (2139)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(6).Case report: acute retinal necrosis following unexpanded gas tamponade acute retinal necrosis following unexpanded gas tamponade.The open ophthalmology journal.2023, vol 17.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported via literature report about two patients presented with decreased visual acuity due to epiretinal membrane, both patients underwent vitrectomy and membrane peeling.The vitrectomy operation was uneventful and was concluded with the insertion of ophthalmic gas tamponade.Both eyes were pseudophakic and had no other ocular or systemic pathology.Patients were controlled 24 hours following the surgery and both presented with normal anterior segment examination and normal intraocular pressure.On the next day of surgery both patients complained of central scotoma, and both had very difficult light perception.Fundus examination showed devitalized macula structures in the presence of gas bubbles occupying almost 100% of the vitreous cavity.Oct (optical coherence tomography) examination done a few days after surgery revealed necrotic retinal tissue.Four weeks later, both eyes had light perception vision, and devitalization of the central macula and spicule-like pigment changes in the midperiphery of the retinal in both eyes.This report is for the first patient (od) involved in this event.
Additional Manufacturer Narrative
A check of the batch production record could not be performed because a valid lot number was not reported.The expiration date could not be determined.A check of the complaint records could not be performed because a valid lot number was not provided.A check of confirmed complaints for ophthalmic gas causing harm to a patient showed no complaints since the beginning of 2016.The sample was not returned.Testing could not be performed.No sample was returned for evaluation.With no additional, related information provided, the customer reported event was not confirmed.At this time, the root cause of the reported event cannot be determined.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: ISPAN SULFUR HEXAFLUORIDE (SF6) GAS
• Common Device Name: INTRAOCULAR GAS
• Manufacturer (Section D): AIRGAS THERAPEUTICS LLC; 6141 easton road; p.o. box 310; plumsteadville PA 18949
• Manufacturer (Section G): AIRGAS THERAPEUTICS LLC; 6141 easton road; p.o. box 310; plumsteadville PA 18949
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17017095
• Report Number: 2518435-2023-00016
• Device Sequence Number: 6296447
• Product Code: LPO
• UDI-Device Identifier: 00380657970056
• UDI-Public: 00380657970056
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P900067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8065797005
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 05/29/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female