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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX P3 F5 8X4 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION POWERFLEX P3 F5 8X4 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 4208040S
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/13/2022
Event Type  Injury  
Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the balloon of an 8mm x 4cm 80cm powerflex p3 percutaneous transluminal angioplasty (pta) balloon catheter ruptured while ballooning a tight lesion within a fistula. The rupture caused the balloon to separate into two pieces and a portion of the balloon was left inside the patient upon removal of the powerflex p3 pta balloon catheter. The left-over portion of the balloon was eventually removed from the patient; however, there was a lot of bleeding, and an unknown covered stent was placed. The patient is now discharged. The device prepped normally and was able to maintain negative pressure. There wasn¿t any difficulty removing the stylet or any of the sterile packaging components and there were no kinks or other damages noted prior to inserting the product into the patient. There was no calcification at the target site, but mild tortuosity was present in the target vessel. The balloon was not being used to post dilate a previously placed stent. Information regarding the removal of the separated balloon segment, contrast media, contrast to saline ratio, inflation pressure, covered stent implantation, bleeding, and possible vessel damage was requested but is unavailable. The device will be returned for evaluation.
 
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Brand NamePOWERFLEX P3 F5 8X4 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 Key13513707
MDR Text Key287558905
Report Number9616099-2022-05339
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
Type of Report Initial,Followup
Report Date 02/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4208040S
Device Lot Number82206888
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2020
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: 02/11/2022 Patient Sequence Number: 1
Treatment
UNKNOWN COVERED STENT
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