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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ECHO Back to Search Results
Catalog Number 5955460
Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/10/2014
Event Type  malfunction  
Event Description
The following was reported to a davol: on (b)(6) 2014, during a surgical procedure, using a ventralight st w/ echo an unintended portion of the device was left in the body.The surgeon after fixating the mesh deflated the echo positioning balloon and attempted to pull it from the body, without having cut the inflation tube below the anchor, per the prescribed method.As a result a portion of the inflation tube got caught between the mesh and the abdomen.The surgeon chose to leave that portion of the inflation tube in place behind the mesh.They removed the remaining portion of the inflation assembly and completed the case.Approx.3-weeks later, the patient required a procedure to repair an intestinal fistula.During the course of the procedure, the previously placed mesh, and portion of the inflation assembly were explanted.
 
Manufacturer Narrative
The sales representative confirmed that this was the surgeons first use of the echo inflation system.The sales rep had demonstrated the use of the product the day before the case and also just before the case.Unfortunately the surgeon did not follow prescribed removal steps.The method is described in the products instruction-for-use(ifu) provided with the device.As the surgeon failed to cut the inflation tube below the portion of the anchor tube that engages the inflator, the anchor was pulled behind the mesh where it became stuck.As was reported the fistula formation and need for surgical intervention appear to be unrelated to the problem that occurred during the implant procedure.This mdr includes all patient, event and device information davol has received to date.If additional information is obtained, a follow up mdr will be submitted.
 
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Brand Name
VENTRALIGHT ST W/ECHO
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
warwick RI
Manufacturer (Section G)
DAVOL INC., SUB. C.R. BARD, INC.
san geronimo industrial park
lot#1, road#3, km 79.7
humacao 0079 1
Manufacturer Contact
laura berg
100 sockanossett crossroad
warwick, RI 02886
8005566756
MDR Report Key4250243
MDR Text Key5105248
Report Number1213643-2014-00403
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K110820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/10/2014
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
Device Operator Health Professional
Device Catalogue Number5955460
Device Lot NumberHUYD1243
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/10/2014
Initial Date FDA Received11/06/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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