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

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX P3 F5 12X4 80 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 CORPORATION POWERFLEX P3 F5 12X4 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4202040S
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2022
Event Type  malfunction  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, there was a leak at the distal balloon tip of a 12mm x 4cm 80cm powerflex p3. 035 percutaneous transluminal angioplasty (pta) balloon catheter. As a result, a new 12mm x 4cm 80cm powerflex p3 pta balloon catheter was successfully used in place of the leaking 12mm x 4cm 80cm powerflex pta balloon catheter. There was no reported injury to the patient and the patient has been discharged. This was during a procedure to treat a calcified right upper arm fistula in the right brachiocephalic vein which had a central stenosis of 80% and an outflow stenosis of 60%. There was no tortuosity present at the target vessel. The 12mm x 4cm 80cm p3. 035 powerflex pta balloon catheter was advanced to the patient¿s central vein and an attempt to inflate the balloon was made. Upon attempted inflation, incomplete balloon filling was observed, and the balloon was deflated and removed easily, remaining in one piece during removal. After removing the powerflex pta balloon catheter, a tiny leak of fluid was observed at the distal balloon tip. There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet, or any of the sterile packaging components. The device maintained negative pressure during preparation and a 40% contrast and 60% saline mixture was used to prep the balloon. There was no resistance or friction experienced as the balloon catheter was being inserted into the patient and the device was never in an acute bend. It was confirmed that the balloon did not fully rupture, there was no evidence of missing pieces, and no evidence of harm to the patient¿s vessel. The device will be returned for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePOWERFLEX P3 F5 12X4 80
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key14086031
MDR Text Key292842325
Report Number9616099-2022-05536
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032737
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4202040S
Device Catalogue Number4202040S
Device Lot Number82227796
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/12/2022 Patient Sequence Number: 1
Treatment
12MM X 4CM 80CM POWERFLEX P3 PTA BALLOON CATHETER
-
-