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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT
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BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT Back to Search Results
Model Number FEM08040
Device Problems Break (1069); Failure to Advance (2524); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2022
Event Type  malfunction  
Event Description
It was reported that during an attempt to treat a subclavian stenosis through a sheath less access site, the delivery system became allegedly stuck on the guidewire and was unable to further advance.Reportedly, the device was removed causing a lost of access.Another device was used to regain access and complete the procedure.There was no patient contact.
 
Manufacturer Narrative
Manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the returned sample analysis could not be performed as the physical device was not returned.Based on the evaluation of the pictures, a break of the inner catheter could be confirmed.An incompatibility between the inner catheter and the guidewire could not be confirmed, since the device was introduced into the patient and other factors may have influenced the impossibility to fully advance the system over the guidewire.Therefore, a failure to advance the system over the guidewire is confirmed as the main issue, which led to the break of the inner catheter.Based on the information available a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding the precautions before the usage of the device, the instructions for use state: 'examine the packaging and endovascular system to determine if there is any damage, defects or if the sterile barrier is compromised.Do not use the device if any of these conditions are observed.' regarding the preparation of the device the instructions for use states 'flush the stent graft lumen with sterile saline by using a small volume syringe.Attach the syringe to the luer port at the back of the endovascular system.Attach the syringe to the luer port on the y adapter, close the stopcock when flushing is complete and remove the syringe from the luer port.The instructions for use states regarding the accessories' prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location' the packaging pictograms indicate a 0.035" guidewire and an introducer size of 9f.Medical device: expiry date: 09/2024.Device not returned.
 
Manufacturer Narrative
H10: manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the returned sample analysis could not be performed as the physical device was not returned.Based on the evaluation of the pictures, a break of the inner catheter could be confirmed.An incompatibility between the inner catheter and the guidewire could not be confirmed, since the device was introduced into the patient and other factors may have influenced the impossibility to fully advance the system over the guidewire.Therefore, a failure to advance the system over the guidewire is confirmed as the main issue, which led to the break of the inner catheter.Based on the information available a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding the precautions before the usage of the device, the instructions for use state: 'examine the packaging and endovascular system to determine if there is any damage, defects or if the sterile barrier is compromised.Do not use the device if any of these conditions are observed'.Regarding the preparation of the device the instructions for use states 'flush the stent graft lumen with sterile saline by using a small volume syringe.A) attach the syringe to the luer port at the back of the endovascular system.B) attach the syringe to the luer port on the y-adapter, close the stopcock when flushing is complete and remove the syringe from the luer port'.The instructions for use states regarding the accessories ' prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location' the packaging pictograms indicate a 0.035" guidewire and an introducer size of 9f.H10: d4 (expiry date: 09/2024).H11:section a through f - the information provided by bd 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 bd.H3 other text : device not returned.
 
Event Description
It was reported that during an attempt to treat a subclavian stenosis through a sheath less access site, the delivery system became allegedly stuck on the guidewire and was unable to further advance.Reportedly, the device was removed causing a lost of access.Another device was used to regain access and complete the procedure.There was no reported patient injury.
 
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Brand Name
FLUENCY PLUS ENDOVASCULAR STENT GRAFT
Type of Device
ENDOVASCULAR STENT GRAFT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM   76227
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13789967
MDR Text Key287343645
Report Number2020394-2022-00178
Device Sequence Number1
Product Code PFV
UDI-Device Identifier04049519008486
UDI-Public(01)04049519008486
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFEM08040
Device Catalogue NumberFEM08040
Device Lot NumberANFW1288
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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