MAUDE Adverse Event Report: AIRGAS THERAPEUTICS LLC ISPAN PERFLUOROPROPANE (C3F8) GAS; INTRAOCULAR GAS

Catalog Number	8065797102
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A case study of an ophthalmic gas used for the vitrectomy, cataract phacoemulsification suction, intraocular lens implantation, vitrectomy injection, pre membrane peeling for complex retinal detachment repair, retinal laser photocoagulation, complex retinal detachment pressure repair, complex retinal detachment repair surgery on the right eye of the patient revealed that the patient experienced high intraocular pressure.Increase in intraocular pressure might be related to gas expansion or transient angle obstruction caused by anterior displacement of the lens and iris during postoperative patient sitting position.
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
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received, indicated that there was no ophthalmic gas expansion.
Additional Manufacturer Narrative
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.However, an analysis of the retained sample lot, showed that the product was perfluoropropane (pfp) and met all release criteria.As a result, nothing was found that would account for the reported.With no additional, related information provided, the customer reported event was not confirmed.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 the assessment, the product met release criteria.A non-conformance-based review of the batch production record for was performed and showed no unusual manufacturing issues.A review for complaints reported for pfp.However, a check of the complaint records showed five other complaints against the lot.As a result, the non-conformance review showed there are potential contributing factor(s).Based upon the information provided, a root cause cannot be conclusively determined.Based upon the information provided, a root cause 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).

• Brand Name: ISPAN PERFLUOROPROPANE (C3F8) 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: 19267127
• Report Number: 2518435-2024-00010
• Device Sequence Number: 7494781
• Product Code: LPO
• UDI-Device Identifier: 00380657971022
• UDI-Public: (01)00380657971022(17)241231(11)230120(10)300502(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2024

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: 8065797102
• Device Lot Number: 300502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 05/15/2024; 07/09/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/12/2024; 08/05/2024
• 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 Sex: Unknown