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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS DE MEXICO MAXI LD PTA F7 110 18X4 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS DE MEXICO MAXI LD PTA F7 110 18X4 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4161840L
Device Problem Difficult to Remove (1528)
Patient Problem Intimal Dissection (1333)
Event Date 10/09/2019
Event Type  Injury  
Manufacturer Narrative
This device is not available for testing and evaluation. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
During a valvuloplasty procedure, a 18mm x 4 cm x 110 cm maxi ld percutaneous transluminal angioplasty (pta) balloon catheter was quickly inflated and deflated, however it did not rewrap properly and was unable to be removed through the sheath. The physician pulled the sheath and the balloon out together but failed. Therefore, urgent dissection surgery was required to remove the device and repair the femoral artery. The product was removed intact in one piece from the patient. There was no other patient injury occur after the femoral artery dissection surgery repair. The patient is currently in the rehabilitation. The device will not be returned for analysis since it was discarded following the procedure. The lesion was calcified, and the device was not used for a chronic total occlusion (total occlusion >3 months). There was no difficulty removing the product from the hoop and protective balloon cover. There was no difficulty removing the stylet or any of the sterile packaging components. There were no kinks or other damages noted before inserting the product the product into the patient. The device prep normally and maintained negative pressure. The contrast to saline ratio was 50/50 and a syringe was used as the inflation device. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and the guide catheter. There was no difficulty advancing the balloon catheter through the vessel. There was no difficulty crossing the lesion. Additional procedural details were requested but are unknown.
 
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Brand NameMAXI LD PTA F7 110 18X4
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS DE MEXICO
circuito int nte 1820
juarez 32575
MX 32575
Manufacturer (Section G)
CORDIS DE MEXICO
circuito int nte 1820
juarez 32575
MX 32575
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9488712
MDR Text Key175895801
Report Number9616099-2019-03413
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K963000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model Number4161840L
Device Catalogue Number4161840L
Device Lot Number82162083
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2018
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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