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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM4CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION POWERFLEXPRO 8MM4CM 135 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 03/02/2022
Event Type  malfunction  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt. This device is available for analysis, but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.
 
Event Description
As reported, the balloons of two powerflex pro 8mm 4cm 135 ruptured at approx 5 atms while inflating in the left common iliac artery. The case was completed with a non-cordis balloon catheter. There was no reported injury to the patient. The balloons were stored and used per ifu and under sterile technique. The device was prepper per the ifu. The device was prepped normally and was able to maintain negative pressure. There was no difficulty removing the device from the hoop or removing the protective balloon cover. There was no difficulty removing the stylet or any of the sterile packaging components. There were no kinks or damages noted prior to inserting the device into the patient. The lesion had a 55-65% stenosis as the device was not being used to treat a chronic total occlusion. The lesion was moderately calcified and non-tortuous. The non-cordis inflation device was filled with 40/60 contrast/saline ratio. Isovue 300 was used to fill the inflation device. The inflation device used was used successfully with other devices. 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 catheter was never in an acute bend nor was the catheter ever kinked while being used. Both products had no issue crossing lesions and no resistance was met on insertion or removal. The device was removed from the patient intact (in one piece). The devices will be returned for evaluation.
 
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Brand NamePOWERFLEXPRO 8MM4CM 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 Key13914637
MDR Text Key290463281
Report Number9616099-2022-05489
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
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 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4400804X
Device Catalogue Number4400804X
Device Lot Number82235799
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2021
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: 03/26/2022 Patient Sequence Number: 1
Treatment
ARMADA BALLOON; BOSTON SCIENTIFIC ENCORE 26-INFLATION DEVICE
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