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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Embolism (1829); Fistula (1862); Hematoma (1884); Unspecified Infection (1930); Occlusion (1984); Stenosis (2263); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess the performance of medtronic¿s pacific plus pta balloon catheter. Survey results received for an interventional cardiologist with 20 years¿ experience. The respondent has been using medtronic¿s pacific plus pta balloon catheter since (b)(6) 2019. Overall, the respondent has used medtronic¿s pacific plus pta balloon catheter in a total of 60 procedures since beginning to use the system all of which have been carried out within the past 12 months. Of these procedures, the devices were used for dilatation of stenoses in patients with obstructive disease in iliac arteries (10), femoral arteries (10), iliofemoral arteries (10), popliteal arteries (10), infrapopliteal arteries (10), renal arteries (5), and 5 during treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The respondent has not used medtronic's pacific plus pta balloon catheter in any other anatomical locations other than those described above. The respondent reports complications of local hematoma, arteriovenous fistula, and local infections associated specifically with puncture which were deemed to be device related. The local hematoma and local infection complications are reported to have been considered as not at all concerning. The arteriovenous fistula complications were reported to have been somewhat concerning. The respondent reports complications of restenosis of the dilated artery, and total occlusion of the peripheral artery associated specifically with dilation which were deemed to be device related. The restenosis of the dilated artery complications are reported to have been considered as somewhat concerning. The total occlusion of the peripheral artery complications were reported to have been considered very concerning. The respondent reports complications of allergic reaction to contrast medium, arrhythmias, short-term hemodynamic deterioration, systemic embolization, and spasm specifically with angiography. All of these events were deemed as being device related. The complications of allergic reaction to contrast medium and arrhythmias were considered as being somewhat concerning. The complications of short-term hemodynamic deterioration, and systemic embolization were considered as being very concerning.

 
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Brand NamePACIFIC PLUS
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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
toni o'doherty
parkmore business park west
galway 
 
091708734
MDR Report Key10688551
MDR Text Key216592165
Report Number9612164-2020-03942
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK123358
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/16/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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