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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number CQF7588
Device Problems Entrapment of Device (1212); Failure to Advance (2524)
Patient Problem Occlusion (1984)
Event Date 04/25/2019
Event Type  malfunction  
Event Description
After ballooning, the surgeon was removing the balloon catheter and a fiber caught the end of stent and moved it. The surgeon was able to put stent back into place. Notes from operative report:. 25 cm 4 french sheath was inserted in hobbs just proximal to the area of pre-existing stent. Using a berenstein catheter support and stiff glidewire, the area of the previously stented portion was able to be crossed and the wire placed past the ventricle into portion of ivc (inferior vena cava). As now the plan was to treat this area with stent graft placement as well as angioplasty, the sheath was upsized to 7 french by 25 cm sheath. The area was predilated using 6 mm x 100 mm angioplasty balloon (conquest, bard). This then allowed for a larger balloon angioplasty using 8 mm x 80 mm angioplasty (conquest, bard). Subsequent to this, an attempt was made to pass the fluency stent graft. However, the distal portion of the pre-existing stents had one of the struts that was preventing the passage of the stent graft. Therefore, stronger support was obtained by switching to supercore wire. During this process, venogram was performed at the level of the vena cava and multiple points, and it was noted that the vena cava appeared to be occluded with flow through the gonadal veins. Next, 8 x 60 mm mustang balloon was utilized (boston scientific) to angioplasty and open up the area of the stent struts. Subsequent to this, the fluency stent graft was able to be passed bareback. 9 x 100 mm fluency covered stent was then deployed from the innominate vein (patient has known right ij [internal jugular] occlusion) into the axillary vein and into now patent portion of the brachial vein. This was post angioplastied with initially the 8 x 80 mm conquest balloon with some infolding noted, therefore repeated with 8 x 60 mm mustang. Postprocedural venogram/fistulogram showed robust and brisk flow through the av graft into the brachial vein into the stent graft and into the right atrium without any hindrance of flow. There was no longer evidence of significant collateral flow as was noted prior to the venous outflow treatment. Clinically, the patient felt immediate relief of pressure within his right upper extremity. There was a palpable thrill within the graft. Patient was taken to recovery room in stable condition.
 
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Brand NameCONQUEST 40
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st
tempe AZ 85281
MDR Report Key8607363
MDR Text Key144956995
Report Number8607363
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCQF7588
Device Catalogue NumberCQF7588
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/03/2019
Event Location Hospital
Date Report to Manufacturer05/14/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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