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

Catalog Number	8065797102
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	01/23/2024
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that, the patient experienced high intraocular pressure (39mmhg) in the left eye after vitrectomy, vitrectomy injection, retinal laser photocoagulation, pre retinal membrane stripping and gas compression surgery.It was also reported that might be related to considering the possible increase in intraocular pressure caused by gas expansion or transient angle obstruction caused by anterior displacement of the lens (artificial) and iris during postoperative patient sitting position, which required medical treatment.The current condition of the patient was recovered from the reported events.
Additional Manufacturer Narrative
The product under investigation is not a serviceable device.Therefore, a service record review was not performed.There was no sample returned for this investigation.Based upon the information provided a root cause cannot be conclusively determined.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.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.Based on the assessment, the product met release criteria.A non-conformance-based review of the batch production record was performed and showed no unusual manufacturing issues.A review for complaints reported for this issue, showed one other complaint.In addition, a check of the complaint records showed five (5) other related complaints again.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.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: 19319641
• Report Number: 2518435-2024-00011
• Device Sequence Number: 7649228
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 04/19/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown