MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. IMPRA DISTAFLO FLEX EPTFE GRAFT

Catalog Number DF6006SC

Device Problems Compatibility Problem (2960); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was 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 of the reported event 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 graft was removed from the packaging and it was noted to be different in size per the label on the packaging.There was no patient involvement.

Manufacturer Narrative

Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.This is the only complaint reported for this lot number and issue to date.Visual/microscopic inspection: the grafted was returned opened; however, all packaging was returned.The graft was clean.The returned graft had two blue lines running down the length of the graft and carbon inner lining, thus identifying it as a bard product.There were no rips, cuts, or holes noted to the graft.Functional/performance evaluation: to confirm the size discrepancy the inner diameter (id) of the returned graft was measured.The id of the graft measured 8.0mm.The returned labeling and packaging indicated the id was to be 6.0mm.In addition, a sales report was performed for the complainant facility, for all distaflo graft purchases in the past five years.It was verified that the facility purchases only 6mm distaflo grafts.Therefore, even though the graft was returned opened, the mix-up could not have occurred at the reporting facility as they would not have an 8mm graft in their inventory to return.Medical records review_ image/photo review: medical records were not provided.No images or photos were provided.Conclusion: the investigation is confirmed, as an 8mm graft was received in an 6mm graft packaging.Based on the investigation performed at the manufacturing site, the component mix-up most likely occurred during the manufacturing of the lot and the label printing process for the work order.Labeling review: the current ifu (instructions for use) states: precautions: only physicians qualified in vascular surgery techniques should use this prosthesis.The healthcare provider is responsible for all appropriate postoperative care instructions to the patient.The healthcare provider must observe aseptic technique during implantation and postoperatively.Opening the package: hold the outer tray in one hand.Peel back the lid.Remove the inner tray.Peel back the inner tray lid slowly and carefully remove the graft using sterile atraumatic instruments or gloves.Protect the graft against damage from sharp or heavy instruments.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.

• Brand Name: IMPRA DISTAFLO FLEX EPTFE GRAFT
• Type of Device: EPTFE GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5076152
• MDR Text Key: 26135088
• Report Number: 2020394-2015-01606
• Device Sequence Number: 1
• Product Code: DYF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DF6006SC
• Device Lot Number: VTZE1782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2015
• 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