MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CARBOFLO EPTFE VASCULAR GRAFT

Catalog Number F8006TWSC

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.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 after implantation of the vascular graft an alleged split was identified approximately 3/4 of the way down from the suture site; therefore, the torn section of the graft was cut and removed.It was further reported that the remainder of the graft was re sutured, and the procedure was completed.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.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 was inconclusive for torn material, as the sample was not returned for evaluation.The definitive root cause could not be determined based upon available information.It was unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current instruction for use (ifu) states: eptfe grafts do not stretch (are non-elastic) in the longitudinal direction.The correct graft length for each procedure must be determined by considering the patient's body weight, posture, and the range of motions across the anatomical area of graft implantation.Failure to cut the graft to an appropriate length may result in anastomotic or graft disruption, leading to excessive bleeding, and loss of limb or limb function, and/or death.Aggressive and/or excessive graft manipulation when tunneling, or placement within a too tight or too small tunnel, may lead to separation of the spiral beading and/or graft breakage.When suturing, avoid excessive tension on the suture line, inappropriate suture spacing and bites, and gaps between the graft and host vessel.Failure to follow correct suturing techniques may result in suture hole elongation, suture pull-out, anastomotic bleeding and/or disruption.Additional mfr narrative: date received by mfr; (conclusion); 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 after implantation of the vascular graft an alleged split was identified approximately ¾ of the way down from the suture site; therefore, the torn section of the graft was cut and removed.It was further reported that the remainder of the graft was re sutured, and the procedure was completed.There was no reported patient injury.

• Brand Name: CARBOFLO EPTFE VASCULAR GRAFT
• Type of Device: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6059392
• MDR Text Key: 58456044
• Report Number: 2020394-2016-01006
• Device Sequence Number: 1
• Product Code: DYF
• UDI-Device Identifier: 00801741021626
• UDI-Public: (01)00801741021626(17)201113(10)VTZK0436
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K004012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2020
• Device Catalogue Number: F8006TWSC
• Device Lot Number: VTZK0436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2015
• 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