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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL POWERFLEX P3 F5 6X8 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL POWERFLEX P3 F5 6X8 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4206080S
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2019
Event Type  malfunction  
Manufacturer Narrative
A device history record (dhr) review of lot 82156676 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. This device is available for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.
 
Event Description
As reported, a 5f powerflex p3 6x8 80 percutaneous transluminal angioplasty (pta) balloon catheter (bc) the balloon would not inflate in the patient, after removal from the patient and the wire, it was found that there was a pinhole at the tip of the balloon by using a syringe. There was no reported patient injury. The procedure was completed using a non-cordis balloon.
 
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Brand NamePOWERFLEX P3 F5 6X8 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 Key8799139
MDR Text Key151332831
Report Number9616099-2019-03082
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Model Number4206080S
Device Catalogue Number4206080S
Device Lot Number82156676
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2018
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: 07/17/2019 Patient Sequence Number: 1
Treatment
UNKNOWN BALLOON CATHETER
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