MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD DEBAKEY DOUBLE VELOUR FABRIC

Catalog Number 007939

Device Problems Loose or Intermittent Connection (1371); Nonstandard Device (1420)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device has been provided.A review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation is currently underway.

Event Description

It was reported that the fibers of the surgical fabric allegedly became loose during surgery of a ventrical septal defect.There was no reported impact or consequence to the patient.

Manufacturer Narrative

The lot number was provided and the lot device history records were reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.Visual inspection & functional/performance evaluation: the device was not returned; therefore, no visual inspection or functional testing of the device was performed.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the investigation is inconclusive.As all bard debakey double velour fabric are 100% visually inspected at manufacturing and a sample is taken from the lot and inspected prior to final release, it is unlikely that the root cause is manufacturing related.The definitive root cause could not be determined based upon available information.Labeling review: the current bard debakey double velour fabric instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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

It was reported that the fibers of the surgical fabric allegedly frayed during surgery of a ventricle septal defect; however, the health care provider chose to continue with the implantation of the fabric.There was no reported impact or consequence to the patient.

• Brand Name: BARD DEBAKEY DOUBLE VELOUR FABRIC
• Type of Device: FABRIC
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5259720
• MDR Text Key: 32559985
• Report Number: 2020394-2015-01951
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K770235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

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 Expiration Date: 02/29/2020
• Device Catalogue Number: 007939
• Device Lot Number: HUZC0756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 12/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2015
• 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 Age: 12 YR