• 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 7MM4CM 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 7MM4CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2019
Event Type  malfunction  
Manufacturer Narrative
The device was returned but the engineering report is pending. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the balloon of 7mm x 40mm x 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc) was ruptured at nominal inflation pressure. Therefore, the product was removed intact (in one piece) from the patient. The procedure was completed with the used of another balloon. There was no reported patient injury. The intended procedure was percutaneous transluminal angioplasty (pta). The target lesion was the superficial femoral artery (sfa). The 80% occluded lesion was calcified and had moderate vessel tortuosity. The device was not used for a chronic total occlusion (total occlusion >3 months). There was no difficulty removing the stylet or any of the sterile packaging components. There was no difficulty removing the product from the hoop. There was no difficulty removing the protective balloon cover. There were no kinks or other damages noted prior to inserting the product into the patient. The device was prep normally and negative pressure was maintained. The contrast had a 1:2 saline ratio. The same indeflator was used successfully with other devices. There was no resistance or friction while inserting the balloon through the rotating hemostatic valve and through the guide catheter. The catheter was not ever in an acute bend. There was difficulty crossing the lesion and advancing the balloon catheter through the vessel. The device is expected to be returned for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePOWERFLEXPRO 7MM4CM 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 Key9458113
MDR Text Key199107129
Report Number9616099-2019-03398
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeKS
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 12/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Model NumberN/A
Device Catalogue Number4400704X
Device Lot Number17672542
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-