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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 10MM10CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION POWERFLEXPRO 10MM10CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4401010X
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2022
Event Type  malfunction  
Event Description
As reported, the balloon of a powerflex pro 10mm 10cm 135 burst before reaching the rated working/burst pressure, below the rbp. The device was removed from the patient intact (in one piece). The case was completed with a non-cordis balloon. There was no reported injury to the patient. The product was stored properly according to the instructions for use (ifu). There was no difficulty removing the device from the hoop. There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components. There were no kinks, or any other damages noted prior to inserting into the patient. The device was prepped per the ifu and was prepper normally. The balloon ruptured while in the superficial femoral artery. The device was able to maintain negative pressure. The balloon was not in a stent when it ruptured. The lesion was noted to have plaque and stenosis. The lesion had moderate calcification with a 35% stenosis. The device was being used to treat a chronic total occlusion (cto). The manual pressure pump was filled with a saline/contrast ratio of 1:1. The same inflation device was used successfully with other devices during the case. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve. There was no resistance/friction while inserting the balloon through the guide catheter. The balloon catheter advanced through the vessel without difficulty. The balloon crossed the lesion without difficulty. The catheter was never in an acute bend. The device will be returned for evaluation.
 
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82222548 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.
 
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Brand NamePOWERFLEXPRO 10MM10CM 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 Key14106971
MDR Text Key292842142
Report Number9616099-2022-05541
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032060124
UDI-Public(01)20705032060124(17)240430(10)82222548
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,Followup
Report Date 09/28/2022
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? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4401010X
Device Catalogue Number4401010X
Device Lot Number82222548
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2021
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
BARD BALLOON; MANUAL PRESSURE PUMP
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