MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX AB; PORCINE SURGICAL MESH

Catalog Number 1150610

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The returned sample has been evaluated and is confirmed for having a tear in the material.Visual examination confirms that the graft had been cut by the user as was reported.This cut presented an edge which allowed for the graft to tear while wet.There is a stretch spot present in the graft consistent with user manipulation at the top of the cut key hole on the same side the tear presented.Manipulation on this side of the cut key hole caused the graft to tear.Damage most likely presented when positioning the graft inside the body.No damage was noted prior to use.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Root cause is use related.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 Description

The following was reported to davol: it was reported that during a laparoscopic hiatal hernia repair the xenmatric ab tore in half.Reportedly, the graft was cut to allow a key hole and when placing to glue in, it tore while handling inside the belly.There was no injury to the patient.The graft was removed from the patient and returned to davol for evaluation.

• Brand Name: XENMATRIX AB
• Type of Device: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 5628266
• MDR Text Key: 44394242
• Report Number: 1213643-2016-00187
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2017
• Device Catalogue Number: 1150610
• Device Lot Number: HUZL0457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2016
• 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