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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 10MM8CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION POWERFLEXPRO 10MM8CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4401008X
Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
Event Type  Injury  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the balloon of a 10mm x 8cm 135cm powerflex pro. 035 percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to 12 atmospheres (atm) in the iliac vein. After the rupture, the powerflex pro was difficult to remove. To remove the powerflex pro pta balloon catheter, transection of the device was required, and an incision at the puncture site was made. Once the balloon was removed, the patient was observed until stabilization and the procedure was ended. The powerflex pro was being used to treat iliac vein in-stent restenosis which was not reported as a chronic total occlusion (cto). The iliac vein had a 75% percent stenosis and showed no signs of calcification or tortuosity. The device was stored and prepared per the instructions for use (ifu) and maintained negative pressure during preparation. There was no difficulty removing the product from the hoop, the protective balloon cover, or any of the sterile packaging components. Hengrui contrast was used, and the device was prepared at a 1:1 contrast to saline ratio. There was no resistance or friction experienced while the balloon was being inserted into the patient, the balloon was able to cross the lesion, and the device was never in an acute bend. The intended procedure was reported as an inferior vena cava (ivc) filter implantation; however, there was no implantation of an ivc filter during this procedure. The device will be returned for evaluation.
 
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Brand NamePOWERFLEXPRO 10MM8CM 135
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 Key14100973
MDR Text Key289169632
Report Number9616099-2022-05539
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K112797
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4401008X
Device Catalogue Number4401008X
Device Lot Number82222563
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2021
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: 04/13/2022 Patient Sequence Number: 1
Treatment
HENGRUI CONTRAST
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