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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 10MM4CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION POWERFLEXPRO 10MM4CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4401004S
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Event Description
As reported, a 10mm x 4cm x 80cm power flex pro percutaneous transluminal angioplasty (pta) balloon catheter was inflated, but the pressure went down, and the balloon became shrunk. The physician repeatedly inflated the balloon twice or three times and the contrast medium leaked from the shaft about 10cm from the tip of the device and was visually confirmed. The device was removed from the body, and it was observed that there was a hole like a ¿pinhole¿ from the shaft part of the balloon lumen. The graph anastomosis was completed successfully. There was no reported patient injury. This was a transcatheter aortic valve implantation (tavi) case. The femoral artery was cut down and inserted an 18f unknown sheath (the femoral artery had a graft implanted). The power flex pro pta balloon was used for hemostasis in a balloon occlusion. The physician inserted the power flex pro pta into the 18f unknown sheath. The sheath was removed and inflated the power flex pro pta at 10 atmospheres (atm) around the external iliac artery and during that time a graft anastomosis was performed. The device will be returned for evaluation.
 
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.
 
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Brand NamePOWERFLEXPRO 10MM4CM 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 Key12852214
MDR Text Key285560630
Report Number9616099-2021-05070
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112797
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 12/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4401004S
Device Catalogue Number4401004S
Device Lot Number82200849
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/05/2020
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: 11/22/2021 Patient Sequence Number: 1
Treatment
UNK 18FR SHEATH
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