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

Catalog Number 8065797102

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Flashers (1864); Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/16/2023

Event Type  Injury  

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 Description

A clinical study stated that high intraocular pressure was high in right eye because of possible increase in intraocular pressure caused by gas expansion and flashes.Patient was prescribed with medication and symptoms resolved.

Manufacturer Narrative

Additional information was provided in sections h.6 and h.10.There was no sample returned.Therefore, testing could not be performed.An analysis of the retain samples lot(s) showed that the product was perfluoropropane (pfp) and met all release criteria.Based upon the information obtained, 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
• Type of Device: 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: 17682772
• MDR Text Key: 322629898
• Report Number: 2518435-2023-00030
• Device Sequence Number: 1
• Product Code: LPO
• UDI-Device Identifier: 00380657971022
• UDI-Public: 00380657971022
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P900066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Male