MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO; SURGICAL MESH

Catalog Number	5955610
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned to davol for evaluation and included the echo ps along with an additional piece of echo ps balloon material that was reported to have been removed from the patient.The ventralight st mesh itself was successfully implanted and remains in the patient.The echo ps balloon was found to be intact with no anomalies noted.The additional piece of balloon material that was returned is identified to be a section of material that is cut off and removed during the manufacturing process.Once placed in the patient the echo ps balloon is inflated.It appears the piece of residual material fell from the assembly into the abdomen.The lot was manufactured in november 2016.To date there have been no other reported complaints for this manufacturing lot of 77 units.We have concluded that the problem was related to an unintended piece of material being present on the assembly.The information provided by bard 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 bard.
Event or Problem Description
It was reported that after installing the ventralight st mesh and removing the echo ps, the doctor found a piece of the balloon material in the abdomen (lying on the omentum).Per hospital contact this piece of material was noted while performing a tap block at the end of the case.The doctor easily removed the material with a grasper through a 10/12 trocar without issue.Contact confirmed there was no patient injury or need for additional intervention.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7084550
• Report Number: 1213643-2017-00979
• Device Sequence Number: 11087158
• Product Code: FTL
• UDI-Device Identifier: 00801741031748
• UDI-Public: (01)00801741031748
• Combination Product (Y/N): N
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2017

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: 10/28/2018
• Device Catalogue Number: 5955610
• Device Lot Number: HUAX0478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1