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

MAUDE Adverse Event Report: CORDIS DE MEXICO POWERFLEXPRO 5MM15CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • 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
 

CORDIS DE MEXICO POWERFLEXPRO 5MM15CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). The device was returned for analysis and the engineering report is pending but will be submitted within 30 days upon receipt.
 
Event Description
During a lower extremity dvt operation, a 5mm15cm 135 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was advanced to the lesion through the long sheath, blood was noted after the indeflator was used to pull negative pressure. The balloon was replaced with a new balloon to complete the procedure and there was no patient injury. The device will be returned for analysis. "it was possible that the balloon was broken, so the balloon was withdrawn and was replaced with a new one. " the 50% occluded target lesion was in the iliac vein with no calcification or vessel tortuosity. The access site was the femoral vein. There was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover and no difficulty removing the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product the product into the patient. The device also prepped normally. The contrast media used was by iodixanol at a 50:50 contrast to saline ratio. A boston scientific inflation device was used. The same indeflator was used successfully with other devices. A cordis sheath and a terumo were also used in the procedure. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and no resistance/friction while inserting the balloon through the guide catheter. There was no difficulty advancing the balloon catheter through the vessel and no difficulty crossing the lesion. The catheter was never in an acute bend and did not inflate normally, it did not inflate. There was no leakage noted from the balloon. The balloon was easily removed from the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePOWERFLEXPRO 5MM15CM 135
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS DE MEXICO
circuito int nte 1820
juarez 32575
MX 32575
Manufacturer (Section G)
CORDIS DE MEXICO
circuito int nte 1820
juarez 32575
MX 32575
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8744000
MDR Text Key150280240
Report Number9616099-2019-03043
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K112797
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Model NumberN/A
Device Catalogue Number4400515X
Device Lot Number82153095
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-