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); Conjunctivitis (1784); Vitreous Floaters (1866); Retinal Detachment (2047); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/30/2022

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 physician reported that in the clinical trial of evaluating the safety of an ophthalmic gas during intravitreal injection a patient experienced rhegmatogenous retinal detachment, cataract development, blurred vision with dark shadow floating in their right eye, the conjunctiva of the right eye was slightly congested, ametropia and patient underwent extra scleral pressure of right eye, phacoemulsification, intraocular lens implantation, vitreous cavity injection, vitrectomy, vitreous puncture, drug injection, membrane stripping before repair of complex retinal detachment, retinal laser photocoagulation and internal pressure repair of retinal detachment (right eye).The patient was given with aminoglycoside antibiotic ointment, corticosteroids eye drops, anticholinergic eye gel, quinolone antibiotics eye drops, aminoglycoside antibiotic injection, antimuscarinic eye drops, corticosteroids suspension eye drops.The patient was generally in good condition, did not complain of discomfort, and the dressing was clean and discharged with medicine.

Manufacturer Narrative

Additional information was provided in sections h.6 and h.10.The perfluoropropane (c3f8) gas tank was not returned for evaluation.A review of the batch production record for lot showed no unusual manufacturing issues.A review of the complaint records showed no other complaints against the lot number.A review of confirmed complaints for patients that have experienced retinal detachment, cataracts, blurred vision, or dark shadows showed no complaints since the beginning of 2015.An analysis of the retain samples of lot numbers showed that the product was perfluoropropane (pfp) and meet all release criteria.The procedure does not comply with the directions for use (dfu).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).

Event Description

Additional information received clarifying the symptoms were resolved.

Manufacturer Narrative

Additional information was provided in section b.5.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: 14251256
• MDR Text Key: 290391453
• Report Number: 1610287-2022-00024
• 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,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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: 11/24/2022
• 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: 34 YR
• Patient Sex: Male
• Patient Weight: 45 KG