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

Catalog Number 007937

Device Problems Material Frayed (1262); Nonstandard Device (1420); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 06/08/2015

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 been returned to the manufacturer for evaluation.The investigation is currently underway.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 fabric allegedly appears to be large-meshed and the quality is not the same as usual.There was no reported patient involvement.

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.Visual inspection: six lot samples were opened.All samples were clean.The edges of the fabrics were inconsistent to the other edges confirming the investigation for frayed edges.The samples were compared to the visual standard in place and did not meet the standard displayed in the procedure.The weave also appears inconsistent across the length of the samples.The remaining sealed sample was evaluated within its packaging.The sample appeared clean.The edges of the fabric was noted to be inconsistent confirming the investigation for frayed edges.The sample was compared to the visual standard in place and did not meet the standard displayed in the procedure.The weave also appears inconsistent across the length of the samples.Functional/performance evaluation: one sample was shipped to bard puerto rico for evaluation.The end item specifications of porosity and size were tested.The sample was found to meet all end items specifications that were tested.Medical records review: medical records were not provided.Image/photo review: no images or photos were provided for evaluation.Conclusion: the investigation is confirmed for material frayed, as the edges of the returned samples were found to be frayed.Additionally the investigation is confirmed for non-standard device, as the fabric's weave appeared inconsistent throughout the sample.A root cause of the frayed edges was found to originate from dull machining blades.Equipment preventive maintenance frequency as well as an additional visual inspection was established at the manufacturing site as a preventative measure.Labeling review: the current ifu (instructions for use) states: contraindications: due to the high permeability of the knitted polyester fabrics, they are contraindicated for use in patients requiring prolonged systemic or high dose heparinization except for use in repair of intracardiac defects.Additionally, specific warnings, precautions and directions for use of the bard debakey double velour fabric are included in the current ifu.

• Brand Name: BARD DEBAKEY DOUBLE VELOUR FABRIC
• Type of Device: POLYESTER 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: 5053286
• MDR Text Key: 25533108
• Report Number: 2020394-2015-01570
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K770835
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• 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: 007937
• Device Lot Number: HUZC0779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2015
• 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