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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO POWERFLEXPRO 6MM22CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CARDINAL HEALTH MEXICO POWERFLEXPRO 6MM22CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2021
Event Type  malfunction  
Manufacturer Narrative
This device is available for analysis but has not yet been received. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
During an interventional procedure, a tech went to take a 6mm22cm 135 powerflex pro percutaneous transluminal angioplasty (pta) balloon out of sterile sleeve to use but there was difficulty removing the balloon. And it ripped off of the shaft. Another powerflex was used to complete the procedure. There was no reported patient injury. The intended procedure was a peripheral intervention. There was no damage to the packaging of the product. It was stored on the shelf outside of procedure room. There was no damage noted to the device prior to attempting to remove it. The tech grasped the hub to gently take the catheter out. There was no excessive force used. Patient details were requested but were not available. The device will be returned for analysis.
 
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Brand NamePOWERFLEXPRO 6MM22CM 135
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CARDINAL HEALTH MEXICO
av prado sur 150 2d0 piso
ciudad de mexico 11000
MX 11000
Manufacturer (Section G)
CARDINAL HEALTH MEXICO
av prado sur 150 2d0 piso
ciudad de mexico 11000
MX 11000
Manufacturer Contact
karla castro
14201 nw 60th ave,
miami lakes, FL 33014
7863138372
MDR Report Key12515538
MDR Text Key272979445
Report Number9616099-2021-04890
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,Followup
Report Date 12/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number4400622X
Device Lot Number82212751
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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