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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 7MM4CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION POWERFLEXPRO 7MM4CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4400804X
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  malfunction  
Manufacturer Narrative
As reported, the balloon of a 7mm x 4cm 80cm powerflex pro. 035 percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to nominal pressure. There was no reported injury to the patient. This was during an endovascular therapy (evt) procedure to treat an iliac lesion. The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation. There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components. The device was not kinked or damaged in any way prior to being inserted into the patient and there was no resistance or friction experienced during insertion. The device was able to track towards the lesion with ease; however, there was difficulty crossing the lesion and the device was put into an acute bend. The balloon catheter was able to be removed easily from the patient and remained in one piece during removal. Information regarding the patient, target vessel characteristics, contrast used, contrast to saline ratio, possible kinking of the device, and the completion of the procedure was requested but not provided. The product was not returned for analysis as it was discarded. A product history record (phr) review of lot 82235789 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿balloon burst - at/below rbp¿ could not be confirmed as the device was not returned for analysis. The exact cause could not be determined. Vessel characteristics, although unknown, may have contributed to the reported event. However, with the limited amount of information provided regarding lesion characteristics and without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the event reported. According to the safety information in the instructions for use, ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding. Balloon pressure should not exceed the rated burst pressure. The rated burst pressure is based on the results of in vitro testing. At least 99. 9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure. Use of a pressure monitoring device is recommended to prevent over pressurization. Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon. Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used. ¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event. Therefore, no corrective or preventive action will be taken at this time.
 
Event Description
As reported, the balloon of a 7mm x 4cm 80cm powerflex pro. 035 percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to nominal pressure. There was no reported injury to the patient. This was during an endovascular therapy (evt) procedure to treat an iliac lesion. The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation. There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components. The device was not kinked or damaged in any way prior to being inserted into the patient and there was no resistance or friction experienced during insertion. The device was able to track towards the lesion with ease; however, there was difficulty crossing the lesion and the device was put into an acute bend. The balloon catheter was able to be removed easily from the patient and remained in one piece during removal. Information regarding the patient, target vessel characteristics, contrast used, contrast to saline ratio, possible kinking of the device, and the completion of the procedure was requested but not provided, and the device was discarded and will not be returned for evaluation.
 
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Brand NamePOWERFLEXPRO 7MM4CM 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 Key14088180
MDR Text Key289667994
Report Number9616099-2022-05537
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 Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4400804X
Device Catalogue Number4400704S
Device Lot Number82235789
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/03/2021
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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