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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SABER 4MM4CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CARDINAL HEALTH MEXICO SABER 4MM4CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2021
Event Type  malfunction  
Manufacturer Narrative
The device was returned but the engineering report is pending. 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 the device preparation procedure, the 4mm x 4cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter could not be flushed because the unknown guidewire lumen port on the balloon was clogged/blocked caused by a blockage of possibly injectable material. So, it could not be used on patient and another saber was used to complete the procedure without any problem. There was no reported patient injury. A percutaneous transluminal angioplasty (pta) of the superficial femoral artery (sfa) was being performed. There was no damage to the device noticed prior to opening the package. There was no difficulty removing the device from the sterile packaging. The device was stored and prepped per the instructions for use. The event occurred during the initial use of the device. Patient demographics and medical history were requested but were not available. The device will be returned for analysis.
 
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Brand NameSABER 4MM4CM 150
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
MX   33014
7863138372
MDR Report Key12568371
MDR Text Key274522150
Report Number9616099-2021-04905
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K971010
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 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number48004004X
Device Lot Number82216762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2021
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: 10/04/2021 Patient Sequence Number: 1
Treatment
UNKNOWN GUIDEWIRE
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