MAUDE Adverse Event Report: AIR LIQUIDE ISPAN PERFLUOROPROPANE (C3F8) GAS; INTRAOCULAR GAS

Catalog Number 8065797102

Device Problem Gas Output Problem (1266)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

No gas tank sample has been received by manufacturing for evaluation.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.Additional information has been requested.This is the second of two reports for this reported event.The manufacturer internal reference number is: (b)(4).

Event Description

A director of nurses reported that an ophthalmic gas and gas dispensing regulator valve were both used during a pars plana vitrectomy (ppv), membrane peel (mp) and internal limiting membrane (ilm) procedure.The instilled gas bubble was not successfully retained inside of the patient's eye.Additional information was requested and received.There was no impact to the patient and no additional treatment or intervention was required.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received further clarified that the ophthalmic gas was used at 14% concentration and was manually mixed with sterile, filtered air at a ratio of 8.5cc gas to 51.5% sterile air.

Manufacturer Narrative

One gas cylinder was returned to the manufacturer for evaluation.Per the manufacturer, the cylinder was in good condition and contained enough gas to analyze.The gas was analyzed by gas chromatograph (gc).The gc analysis confirmed the gas to be perfluoropropane with an air concentration of not more than 100 ppm and with no unusual gc peaks.The product met the release specification.Per the manufacturer, a review of the manufacturing records for the reported lot number showed no unusual issues.A check of the complaint records showed no other related complaints against the reported lot.A review of confirmed complaints showed no trends for reported event.Whenever a sample of a product that did not stay in the eye as long as expected was returned for testing, the sample has met all specifications for release.Per the manufacturer, the returned sample met specifications therefore, the root cause of the reported event could not be determined and no further actions will be pursued at this time.Quality assurance has reviewed this complaint and 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): AIR LIQUIDE; 13140 ti blvd.; dallas TX 75243
• MDR Report Key: 8248575
• MDR Text Key: 133227550
• Report Number: 1610287-2019-00002
• Device Sequence Number: 1
• Product Code: LPO
• Combination Product (y/n): N
• PMA/PMN Number: P900066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 8065797102
• Device Lot Number: 725611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR