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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM8CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION POWERFLEXPRO 8MM8CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4400808X
Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2021
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint. It is unknown if the device will be returned for testing and evaluation.    additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, after the powerflex pro 8mm8cm 135 balloon catheter was removed from the packaging, it was found that the delivery system at the head-end of the balloon was seriously kinked and split but not yet separated. There was no reported patient injury. The intended procedure was a limb artery balloon angioplasty. The lesion was moderately calcified. There was no vessel tortuosity. The percentage of stenosis was 70%. The device was used for a chronic total occlusion (total occlusion >3 months). The product was received in this condition. The product was stored properly according to the instructions for use (ifu). There was no damage noted to the product packaging upon inspection prior to use. There was no reported difficulty removing the product from the packaging. There was no damage noted to the box, pouch or hoop. The procedure was completed with another unknown balloon. The product is expected to be returned for evaluation.
 
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Brand NamePOWERFLEXPRO 8MM8CM 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 Key13017900
MDR Text Key285842623
Report Number9616099-2021-05199
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4400808X
Device Catalogue Number4400808X
Device Lot Number82200845
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/05/2020
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: 12/16/2021 Patient Sequence Number: 1
Treatment
UNK BALLOON
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