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 Cataract (1766); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/10/2023

Event Type  Injury  

Event Description

A clinical study reported that 60 years old female patient underwent posterior vitrectomy surgery, surgeon found that the ophthalmic gas content was less than half during the surgery.Again, surgery was conducted for ophthalmic gas installation in the eye.After the surgery, surgeon observed that there was anterior chamber flickers in the eye, blood cells attached on cornea, cells, high crystal density noted in patient eye.Symptoms were treated with medications.Symptoms are improving.

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).

Manufacturer Narrative

Additional information is provided in sections h.6 and h.10.A check of the batch production record showed no unusual manufacturing issues.A check of the complaint records showed no other complaints against this lot.A check of confirmed complaints for c3f8 (pfp) utilization resulting in low gas content in the eye and/or anterior chamber flicker showed no other complaints since the beginning of 2016.There was no sample returned for evaluation.An analysis of the retain sample this lot showed that the product was pfp and met ail release criteria.Nothing was found that would account for the reported event.The root cause of the reported event cannot be 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: 17624222
• MDR Text Key: 321959497
• Report Number: 2518435-2023-00028
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065797102
• Device Lot Number: 216804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female