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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 244 S DE RL DE CV AVIATOR PLUS .014 5.0X40 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CARDINAL HEALTH MEXICO 244 S DE RL DE CV AVIATOR PLUS .014 5.0X40 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2021
Event Type  malfunction  
Manufacturer Narrative
Telephone number: (b)(6). 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
A. 014 5. 0x40 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter ruptured at nominal pressure during use. There was no reported patient injury. The device will be returned for analysis.
 
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Brand NameAVIATOR PLUS .014 5.0X40 142CM
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CARDINAL HEALTH MEXICO 244 S DE RL DE CV
santiago troncoso 808
juarez 32574
MX 32574
Manufacturer (Section G)
CARDINAL HEALTH MEXICO 244 S DE RL DE CV
santiago troncoso 808
juarez 32574
MX 32574
Manufacturer Contact
karla castro
14201 nw 60th ave,
miami lakes, FL 33014
7863138372
MDR Report Key13017960
MDR Text Key286124885
Report Number9616099-2021-05200
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K071189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/06/2022
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 NumberN/A
Device Catalogue Number4245040W
Device Lot Number82185849
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2020
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.
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