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

Catalog Number	8065797102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A healthcare professional reported that during vitrectomy, cataract phacoemulsification, intraocular lens implantation, vitrectomy injection, retinal laser photocoagulation, pre membrane stripping for complex retinal detachment repair, gas compression surgery on the right eye patient experienced intraocular hypertension (26 mmhg).Patient was treated with drug and symptoms were resolved.
Additional Manufacturer Narrative
There were no samples returned for testing on this investigation.The device master record.Based on the assessment, the product met release criteria.A check of the batch production record showed no unusual manufacturing issues.A non-conformance based review of the lot number was performed and a potential contributing factor to the reported complaint was identified.Nonconformance investigations were opened for issues but were later determined not be relevant to this investigation.A review for complaints reported against this lot number was performed.Seventeen other potentially relevant complaints were found and reviewed as part of this complaint.Manufacturer also performed a similar complaint review for this lot number.A check of the complaint records showed 16 other complaints against the lot.These are all reports from a clinical study.Also did a check of confirmed complaints for perfluoropropane (pfp) causing high intraocular pressure or other medical issues.The sample was not returned.Testing could not be performed by the manufacturer.An analysis of the retain samples lots showed that the product was pfp and met all release criteria.Based on the information obtained, the root cause of the reported event is inconclusive.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.

• 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: 19459233
• Report Number: 2518435-2024-00016
• Device Sequence Number: 6661901
• Product Code: LPO
• UDI-Device Identifier: 00380657971022
• UDI-Public: (01)00380657971022(17)230731(11)210817(10)121407(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
• Report Date (Section B): 08/25/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 8065797102
• Device Lot Number: 121407
• 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: 08/01/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 08/25/2024
• Date Device Manufactured: 08/17/2021
• 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
• Patient Sex: Unknown