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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 Leak/Splash (1354); Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use pacific plus pta balloon along with non-medtronic 5fr sheath and 0. 014" guidewire during procedure to treat a little calcified soft tissue lesion in the left mid popliteal artery with 60% stenosis. The vessel was none tortuous. The vessel diameter and lesion length are 4. 8mm and 115mm respectively. No embolic protection was used. A non-medtronic inflation device was used for balloon inflation. Visipaque 320 was used for inflation fluid. Thee was no damage noted to packaging. There was an issue noted when removing device from hoop/tray. It was reported that physician noted when removing balloon out of the hoop that the mandrel is still in place, when mandrel was removed, it was noted that the balloon was bent. The product was damaged out of the package. Physician decided to try and use the balloon and could advance the balloon to the lesion site with no effort. When balloon was inflated, it was noted that contrast leaked out of the proximal balloon attachment site, where the issue was noted. The device was flushed per ifu with no problem noted. During inflation, leak was noted at the transition shaft. All fragments of the balloon was retrieved. The device passed through a previously deployed stent. No resistance encountered when advancing or removing the device. The device was removed and a non-medtronic dcb was used to complete the procedure. There was no patient injury.
 
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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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key11250968
MDR Text Key229338082
Report Number9612164-2021-00386
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSF
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,Followup,Followup
Report Date 07/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/08/2021
Device Catalogue NumberPCE050120090
Device Lot Number215416853
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/2018
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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