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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 4MM22CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION POWERFLEXPRO 4MM22CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4400422X
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2022
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82222609 presented no issues during the manufacturing process that can be related to the reported event. 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, a 4mm x 22cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was found to be cracked during a balloon inflation to 10 atmospheres (atm). As a result, the balloon was immediately deflated and the device was replaced with another 4mm x 22cm cordis balloon catheter to complete the procedure. There was no reported injury to the patient. This was during a procedure to treat a 70% stenosis in the superficial femoral artery (sfa) in which the powerflex pro pta balloon catheter was used for pre-dilation of the lesion. There was no calcification or tortuosity to the target vessel and the lesion was not a chronic total occlusion (cto). There was no difficulty removing the product from the hoop, protective balloon cover, the stylet, or any of the sterile packaging components. The device maintained negative pressure during preparation and an unknown inflation device was prepped with bayer contrast at a 1:1 contrast to saline ratio. The same, unknown inflation device was used successfully with other devices during the procedure. There was no resistance or friction experienced as the balloon entered the patient. There was no difficulty advancing the balloon catheter through the vessel, no difficulty crossing the lesion, and the device was never in an acute bend. The crack was visualized by evidence of an outflow of contrast agent form the device; however, the device did not separate as a result of the damage and was removed in one piece. Additionally, there was a noticeable drop in atmospheres upon the crack to the device. The device will be returned for evaluation.
 
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Brand NamePOWERFLEXPRO 4MM22CM 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 Key13996566
MDR Text Key291238801
Report Number9616099-2022-05510
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
Report Date 04/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4400422X
Device Catalogue Number4400422X
Device Lot Number82222609
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/20/2021
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: 04/04/2022 Patient Sequence Number: 1
Treatment
4MM X 22CM CORDIS BALLOON CATHETER; BAYER CONTRAST; UNKNOWN INFLATION DEVICE
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