MAUDE Adverse Event Report: NEOMEND INC -2953195 PROGEL PLEURAL AIR LEAK SEALANT; SEALANT, POLYMERIZING

Catalog Number	PGPS002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a video-assisted thoracoscopic surgery (vats) wedge procedure with pleurodesis on (b)(6) 2022, while applying the progel one of the vials cracked.As reported excessive force was not used and the product was attempted to be used within 20 minutes of dissolving the peg per the instructions-for-use.It was reported the product was properly stored between 2-8 degrees centigrade.As reported the or staff was not familiar with the progel product.The procedure was completed with another kit and there was no reported patient injury.
Additional Manufacturer Narrative
As reported, the progel glass vial cracked when applying.The subject device was not returned for evaluation.Based on the information provided and without having the sample to evaluate, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 138 units released for distribution in april 2022.The instructions-for-use, supplied with this device states ¿without the spray tip attached, point the applicator housing upward and load each cartridge into the dual-barrel applicator housing.Cartridges can be loaded into the delivery system in any order.Gently press the cartridges to seat them into place.Note: when properly loaded the chemistry cartridges should sit flush with the end of the applicator housing.¿ and ¿without the spray tip attached, point the applicator housing upward to allow any air in the chemistry to rise to the top of the cartridges.Insert the locking push rod into the openings in the rear of the cartridges until it snaps into place.Note: during applicator assembly, the progel¿ push rod is designed to lock into the applicator housing.Forced removal of the locking push rod from the applicator housing may result in potential damage to the applicator system or the chemistry cartridges.Not returned.
Additional Manufacturer Narrative
As reported, the progel glass vial cracked when applying.The subject device was not returned for evaluation.Based on the information provided and without having the sample to evaluate, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 138 units released for distribution in april 2022.The instructions-for-use, supplied with this device states ¿without the spray tip attached, point the applicator housing upward and load each cartridge into the dual-barrel applicator housing.Cartridges can be loaded into the delivery system in any order.Gently press the cartridges to seat them into place.Note: when properly loaded the chemistry cartridges should sit flush with the end of the applicator housing.¿ and ¿without the spray tip attached, point the applicator housing upward to allow any air in the chemistry to rise to the top of the cartridges.Insert the locking push rod into the openings in the rear of the cartridges until it snaps into place.Note: during applicator assembly, the progel¿ push rod is designed to lock into the applicator housing.Forced removal of the locking push rod from the applicator housing may result in potential damage to the applicator system or the chemistry cartridges.Addendum: h11: this supplemental mdr is submitted to correct medical device manufacturer and unique identifier (udi).Updated fields: b4, g3, g6, h2, h10, h11.Corrected fields: d3 (medical device manufacturer), d4 (unique identifier (udi)).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, during a video-assisted thoracoscopic surgery (vats) wedge procedure with pleurodesis on (b)(6) 2022, while applying the progel one of the vials cracked.As reported excessive force was not used and the product was attempted to be used within 20 minutes of dissolving the peg per the instructions-for-use.It was reported the product was properly stored between 2-8 degrees centigrade.As reported the or staff was not familiar with the progel product.The procedure was completed with another kit and there was no reported patient injury.

• Brand Name: PROGEL PLEURAL AIR LEAK SEALANT
• Common Device Name: SEALANT, POLYMERIZING
• Manufacturer (Section D): NEOMEND INC -2953195; 60 technology drive; irvine CA 92618
• Manufacturer (Section G): NEOMEND INC -2953195; 60 technology drive; irvine CA 92618
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 15587271
• Report Number: 1213643-2022-00647
• Device Sequence Number: 20620381
• Product Code: NBE
• UDI-Device Identifier: 00801741010026
• UDI-Public: (01)00801741010026(17)231202(10)IRGQ0023
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2023
• Device Catalogue Number: PGPS002
• Device Lot Number: IRGQ0023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown