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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 Burst Container or Vessel (1074)
Patient Problems No Information (3190); Insufficient Information (4580)
Event Type  malfunction  
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 30 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 17 procedures since beginning to use the system. Of these procedures, the devices were used for dilatation of stenoses in patients with obstructive disease in iliac arteries (4), femoral arteries (2), iliofemoral arteries (8), infrapopliteal arteries (2) and renal arteries (1). All of these procedures were carried out in the past 12 months. 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 balloon rupture associated specifically with dilation. The balloon rupture event was deemed as being device related and considered as being not at all concerning as it was expected as the lesion was severely calcified.
 
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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 Key10688545
MDR Text Key219189586
Report Number9612164-2020-03941
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K123358
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2021
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? No
Is this a Product Problem Report? Yes
Device Operator
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 Received01/06/2021
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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