• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC MEXICO PACIFIC XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number PCU050300130
Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2021
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 the pacific xtreme balloon during procedure to treat moderately calcified lesion in the distal mid right superficial femoral artery (sfa). The vessel had little tortuosity. The artery diameter was 5mm and lesion length was 300mm. The balloon was inflated with an inflation device. Half contrast half saline inflation fluid was used. There was no damage noted to packaging, i. E. Shelf carton, hoop/tray and no issues noted when removing the device from the hoop/tray. The device was prepped per ifu with no issues. It was reported that there were balloon inflation difficulties at 6am. It was reported that there was a balloon wrap. A rewrap issue was not noted.  balloon was placed in distal sfa and inflated, twist was recognized and balloon was deflated. Contrast would not come out of distal portion of balloon due to the wrap so physician had to pull balloon back across lesion to deflate  the device did not pass through a previously-deployed stent. No resistance was encountered when advancing the device. No patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePACIFIC XTREME
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 Key14216767
MDR Text Key290154904
Report Number9612164-2022-01596
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08033477076102
UDI-Public08033477076102
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103464
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCU050300130
Device Catalogue NumberPCU050300130
Device Lot Number221370450
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-