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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 Problem Thrombosis (2100)
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 5 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 35 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 (10), femoral arteries (10), iliofemoral arteries (5), popliteal arteries (5), and infrapopliteal arteries (5). 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 thrombosis associated specifically with puncture. The complications of thrombosis were deemed as being related to the device.
 
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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 Key10688661
MDR Text Key216395767
Report Number9612164-2020-03945
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodePL
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
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
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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