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	Eye Injury (1845); Intraocular Pressure Decreased (4468)
Date of Event	01/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that after vitrectomy surgery some complications were observed in the patients after they receiving gas in the eye.Its reported that there was spontaneous drops in intraocular pressure intraoperatively which resulted in temporary intraoperative disconnection of the choroid.The customer has also provided the information which states due to the diagnosed thromboembolic changes, vascular treatment was implemented during a follow-up visit after 2 weeks - improving retinal circulation.
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.11.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.There was no product returned for this investigation.Based upon the information obtained, the root cause of the reported event cannot be conclusively determined.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on qa assessment, the product met specifications at the time of release.A non-conformance based review of the lot number was performed and a potential contributing factor to the reported complaint was identified.Airgas performed a check of the batch production record for this lot and no unusual manufacturing issues were shown.A review for complaints reported against this lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.A check of the complaint records showed no other complaints against this lot.Airgas therapeutics also performed a similar complaint review for this lot number.A check of the complaint records showed no other complaints against this lot.They also performed a complaint search for intra ocular pressure (iop) decreased or choroid disconnection and found no complaints.Based upon the information obtained, the root cause of the reported event cannot be conclusively 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Corrected information is provided in b.5.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A physician reported that after vitrectomy surgery some complications were observed in the patients after they are receiving gas in the eye.Its reported that there was spontaneous drops in intraocular pressure intraoperatively which resulted in temporary intraoperative disconnection of the choroid.The customer has also provided the information which states due to the diagnosed thromboembolic changes, vascular treatment was implemented during a follow-up visit after 2 weeks - improving retinal circulation.Additional information received stating that eight patients were impacted with the reported event.

• 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: 19360418
• Report Number: 2518435-2024-00014
• Device Sequence Number: 6341909
• Product Code: LPO
• UDI-Device Identifier: 00380657970056
• UDI-Public: (01)00380657970056(17)250331(11)230510(10)310907(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Followup
• Report Date (Section B): 01/30/2025

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 Expiration Date: 03/31/2025
• Device Catalogue Number: 8065797005
• Device Lot Number: 310907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 08/26/2024; 01/10/2025
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 09/21/2024; 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION SURGICAL PROCEDURE PAK.; CONSTELLATION VISION SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown