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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. IMPRA EPTFE VASCULAR GRAFT Back to Search Results
Model Number F7007TWS
Device Problem Torn Material (3024)
Patient Problem No Patient Involvement (2645)
Event Date 06/07/2017
Event Type  malfunction  
Manufacturer Narrative
No hospital/medical records or 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 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 during preparation of a surgical graft, a tear in the graft occurred while removing the beading.A new surgical graft was prepped and implanted without incident.There was no reported patient injury.
 
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.The device history records showed that all process parameters were within specification and that lot of grafts passed all physical testing requirements.Visual/microscopic inspection: the graft was returned in two segments.Blue lines were identified on the segments of the graft.Tears along the beading track were observed on the first segment.No tears, suture marks, or holes were noted along the second segment.Dimensional evaluation: the total length of the two segments was measure to be 59.5 cm.However, it is unknown whether the graft portions had been trimmed and the remaining portion may have been discarded.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: as medical images were not provided, a review could not be performed.Conclusion: the device was returned for evaluation in two separate segments.The first segment was noted to have tears along the beading track.The second segment was noted not to have any tears along the length.Therefore, the investigation is confirmed for torn material.The root cause could not be determined based upon available information.It is unknown whether procedural factors contributed to the event.Labeling review: the current ifu (instructions for use) states: warnings do not remove the external spiral support (beading) from any centerflex¿ graft or endflex¿ graft.Attempts to remove the beading may damage the graft wall.If damage occurs, discard the graft precautions when removing the external spiral support (beading) of impra flex¿ grafts, the beading must be removed slowly and at a 90° angle to the graft.Rapid unwinding and/or removal at less than a 90° angle may result in graft damage.Do not use surgical blades or sharp, pointed instruments to remove the beading as this may damage the graft wall.If damage occurs, that segment of the graft should not be used.
 
Event Description
It was reported that during preparation of a surgical graft, a tear in the graft occurred while removing the beading.A new surgical graft was prepped and implanted without incident.There was no reported patient injury.
 
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Brand Name
IMPRA 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 Key6688585
MDR Text Key79137338
Report Number2020394-2017-00763
Device Sequence Number1
Product Code DSY
UDI-Device Identifier00801741023262
UDI-Public(01)00801741023262
Combination Product (y/n)N
PMA/PMN Number
K004011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/24/2017
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 Date07/29/2021
Device Model NumberF7007TWS
Device Catalogue NumberF7007TWS
Device Lot NumberVTAU0915
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/08/2017
Initial Date FDA Received07/05/2017
Supplement Dates Manufacturer Received08/09/2017
Supplement Dates FDA Received08/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age78 YR
Patient Weight59
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