MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PROGEL PLUERAL AIR LEAK SEALANT; SEALANT, POLYMERIZING

Catalog Number PGPS002

Device Problems Loss of or Failure to Bond (1068); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Injury (2348)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the progel was applied as a secondary closure and no submersion was performed to identify if a leak was present at the time of application.Based on the information provided, the source of the air leak that presented cannot be determined.A review of the manufacturing records was performed and found that the lot was manufactured to specification.No definitive conclusions can be made regarding the surgeons report of a difference in the consistency of the product and if the progel contributed to the air leak that presented.The ifu for the progel product instructs: allow the progel¿ pals to cure for 15-30 seconds, forming a flexible hydrogel.Two minutes after application, the sealant¿s success in sealing the target site(s) can be tested using a submersion test or by irrigating the site to check for air bubbles.Pulmonary air leak is listed as one of the potential adverse effects associated with the device.Discarded by user facility.

Event Description

It was reported that during a decortication, progel was applied to the area as secondary closure, and a difference in the consistency of the product was noted.The surgeon felt that when used, it clumped up a bit and didn¿t seal the lung effectively.The patient experienced an air leak and was kept in the hospital until it resolved.There was no submersion performed to identify if a leak was present at the time of application of the progel.No intervention was required and the leak resolved on its own without treatment.

• Brand Name: PROGEL PLUERAL AIR LEAK SEALANT
• Type of Device: SEALANT, POLYMERIZING
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): NEOMEND INC -2953195; 60 technology drive; irvine CA 92618
• Manufacturer Contact: anna smith ; 100 crossings blvd.; warwick, RI 02886 ; 4018258449
• MDR Report Key: 8202501
• MDR Text Key: 131598440
• Report Number: 1213643-2018-04953
• Device Sequence Number: 1
• Product Code: NBE
• UDI-Device Identifier: 00801741010026
• UDI-Public: (01)00801741010026
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2019
• Device Catalogue Number: PGPS002
• Device Lot Number: 170621-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization