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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX EXTREME 10X6 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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CORDIS CORPORATION POWERFLEX EXTREME 10X6 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number UNKPOWERFLEXPRO
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2022
Event Type  malfunction  
Event Description
As reported, three powerflex extreme balloons were sent; however, two of three leaked during positive pressure while inflating.There was no reported injury to the patient as they were not used in the patient.The product was stored per the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, or removing the stylet/sterile packaging components.The device was prepped per the ifu.It was prepped normally and was able to maintain negative pressure.An indeflator was used with pure water to inflate the balloon.The same indeflator was used successfully with other devices.The catheter was never in an acute bend.The devices will not be returned for evaluation.
 
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, three powerflex extreme balloons were sent; however, two of three leaked during positive pressure while inflating.There was no reported injury to the patient as they were not used in the patient.The product was stored per the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, or removing the stylet/sterile packaging components.The device was prepped per the ifu.It was prepped normally and was able to maintain negative pressure.An indeflator was used with pure water to inflate the balloon.The same indeflator was used successfully with other devices.The catheter was never in an acute bend.The devices will not be returned for evaluation.
 
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82226909 presented no issues during the manufacturing process that can be related to the reported event.As reported, three powerflex extreme balloons were sent; however, two of three leaked during positive pressure while inflating.There was no reported injury to the patient as they were not used in the patient.The product was stored per the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, or removing the stylet/sterile packaging components.The device was prepped per the ifu.It was prepped normally and was able to maintain negative pressure.An indeflator was used with pure water to inflate the balloon.The same indeflator was used successfully with other devices.The catheter was never in an acute bend.The product was not returned for analysis.A product history record (phr) review of lot 82226909 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage-during positive pressure ¿ were not confirmed as the devices were not returned for analysis, the exact cause could not be determined.It is likely that procedural factors or handling of the products may have contributed to the reported event.However, without the return of the devices for analysis and with the limited information provided regarding procedural factors, it is difficult to draw a clinical conclusion between the devices and the events reported.According to the safety information in the instructions for use ¿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.To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis.When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.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.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive action will be taken at this time.
 
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Brand Name
POWERFLEX EXTREME 10X6 80CM
Type of Device
CATHETER, 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 Key13772829
MDR Text Key287808391
Report Number9616099-2022-05458
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032001561
UDI-Public(01)20705032001561(17)240731(10)82226909
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K032737
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 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNKPOWERFLEXPRO
Device Catalogue NumberUNKPOWERFLEXPRO
Device Lot Number82226909
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2022
Date Device Manufactured08/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNK.
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