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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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MEDTRONIC MEXICO PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Catalog Number PCE050120090
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Vascular Dissection (3160)
Event Date 02/09/2022
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use the pacific plus balloon during procedure on the la of the left groin with 12 ml of xylocitin 2% in the area of the scar. Heparin 500 iu i. A. Sterofundin 500 ml iv were administered to the patient during the procedure. Ifu was followed. Sonography-guided puncture of the left afc was conducted. A 4 fr non-medtronic sheath 10 cm was inserted in the patient. A non-medtronic wire with a curved tip, which is severely meandering as a result of iliac artery elongation, is passed up. Tracking with a non-medtronic catheter. With this, the wire can only be passed to the middle of the pelvis, here due to the pronounced elongation of the iliac artery, also in the right pelvis axis, there is no possibility of continuing the wire, but repeated ejection back into the aorta. Decision to puncture the right afc antegrade despite severe vascular calcification. Using sonography, it was possible to puncture the afs outlet at a slightly less calcified site after la with 12 ml xylocitin 2% and to insert a 4 fr non-medtronic sheath 10 cm into the afs. Manual angiography on the leg flow path showing multiple severely calcified afs stenosis beginning in the middle third to the distal third. Wire passage with a non medtronic wire with partly subtotal degree of stenosis. Then a straight 4 fr catheter is guided into the popliteal artery and the catheter is carefully sprayed with diluted contrast medium to check the intraluminal position. The pacific plus pta catheter 5/120 mm was then used and balloon dilation in stages for 1. 5 minutes each with up to 10 atm to treat the stenosis. The balloon catheter was then attempted to be removed. It was reported that there were removal difficulties. There was difficulty removing balloon following balloon inflation. The device was stuck in the sluice. The physician mobilized again caudally and sucked out the liquid from the balloon again with a 5 ml syringe. The physician tried removing again and the catheter with the balloon sections got stuck in the sheath. When trying to remove the catheter, the balloon segment detached, which fortunately was stuck in the sheath. The balloon was removed with introducer sheath to complete procedure. All components were removed from patient. Control angiography over the left side after introducing a non-medtronic device over the non-medtronic wire, residual stenosis in the afs with short dissection without possibility of stenting, because of the missing ipsilateral sheath. Completion of the intervention after angiography of the left leg: high-grade restenosis of the femoral bifurcation and meanwhile occlusion of the left popliteal artery up to the trifurcation. No patient injury reported.
 
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Brand NamePACIFIC PLUS
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13597046
MDR Text Key286111767
Report Number9612164-2022-00784
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K123358
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPCE050120090
Device Lot Number222611391
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/25/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/25/2022 Patient Sequence Number: 1
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