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

Catalog Number	8065797002
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that a patient underwent pars plana vitrectomy (ppv) procedure for retinal detachment.The macula was attached by using the intravitreal injection of sulphur hexafluoride (sf6) gas and cryoretinopexy.Post-operatively it was observed that the sf6 gas decreased and did not cover the causative retinal break.The patient required perfluoro propane (c3f8) injection and the gas was expanded with attachment of the macula.The patient condition improved and was discharged.
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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in sections h.6 and h.10.The gas tank was not returned for evaluation.A review of the batch production record showed no unusual manufacturing issues.A review of the complaint records showed one other complaint against the reported lot.A review of confirmed complaints for the product did not stay in the eye as long as expected showed no complaints since the beginning of 2015.An analysis of the retained samples showed that the product was sf6 (sulfur hexafluoride) and met all release criteria.Nothing was found that would account for the reported event.The root cause of the reported event cannot be determined.The 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: 15012098
• Report Number: 1610287-2022-00049
• Device Sequence Number: 15148927
• Product Code: LPO
• UDI-Device Identifier: 00380657970025
• UDI-Public: 00380657970025
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P900067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 8065797002
• Device Lot Number: 117308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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: Required Intervention
• Patient Sex: Unknown