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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL POWERFLEX P3 F5 5X4 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL POWERFLEX P3 F5 5X4 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4205040S
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/25/2019
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82166724 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, a 5mmx40mm powerflex p3 percutaneous transluminal angioplasty (pta) balloon catheter (bc) ruptured at 10 atmospheres (atm) while treating an arterial graft anastomosis de-clot. Therefore, the device was removed intact (in one piece) from the patient without incident and replaced with another powerflex p3 balloon subsequently and the procedure was completed without further complication. There was no reported patient injury. The device will not be returned for evaluation as it was discarded. The device was stored and handled as per the instruction for use (ifu). There was no damage noted to the packaging of the device prior to use. The device was prepped according to the ifu. The device was prepped normally (i. E. Maintain negative pressure). There was no difficulty removing the product from the hoop. There was no difficulty removing the protective balloon cover. There was 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. A non-cordis contrast media was used with 50/50 contrast to saline ratio. The target lesion was the arterial graft anastomosis. The lesion was not calcified. There was no vessel tortuosity. The device was not used for a chronic total occlusion (total occlusion >3 months). The percentage of stenosis was 100 %. A non-cordis inflation device was used (indeflator/syringe). The same indeflator was used successfully with other devices. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve. There was no resistance/friction while inserting the balloon through the guide catheter. There was no difficulty advancing the balloon catheter through the vessel. There was no difficulty crossing the lesion. The catheter was never in an acute bend. The plunger was depressed into the syringe/indeflator when trying to inflate. The user was able to depress the plunger into the syringe/indeflator when trying to inflate. The balloon was delivered to the target site. The maximum inflation pressure was 10 atmospheres (atms). The balloon did not seem to ¿stick¿ to a stent post dilation. The balloon catheter did not kink while being used.

 
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Brand NamePOWERFLEX P3 F5 5X4 80
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9507497
MDR Text Key200251517
Report Number9616099-2019-03426
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK032737
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/20/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number4205040S
Device Catalogue Number4205040S
Device LOT Number82166724
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/14/2019
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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