• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION AVIATOR PLUS .014 4.0X30 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CORDIS CORPORATION AVIATOR PLUS .014 4.0X30 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 4244030W
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2022
Event Type  malfunction  
Manufacturer Narrative
As reported, during a procedure the balloon of a 4mm x 30mm 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter would not inflate. There was no reported injury to the patient. Additional information was requested but was not provided. One product was returned for analysis. A non-sterile aviator plus. 014 4. 0x30 142cm percutaneous transluminal angioplasty (pta) was received for analysis inside a plastic bag. Per visual analysis, no physical characteristics could be observed by the naked eye. Per functional analysis, a lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the unit and pressure was applied. A balloon leakage was observed coming from a rupture in the middle area of the balloon. No other anomalies were observed. Per microscopic analysis, the unit was inspected under the vision system and the balloon rupture was confirmed on the middle section of the balloon. Sem analysis was performed, results showed that the balloon rupture on the inner surface presented no anomalies near the balloon damage. The outer surface presented evidence of scratch marks near the balloon rupture. This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage. It is very likely that the same factors that caused the observed scratch marks on the balloon outer surface could have led to the ruptured condition found on the received device. It seems the balloon material near the rupture was damaged either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon. No other anomalies were observed during the sem analysis. A product history record (phr) review of lot 82186614 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿balloon burst¿ was confirmed via device analysis. However, the exact cause cannot be determined. A rupture was observed on the middle section of the balloon during inflation testing. The outer surface of the balloon presented evidence of scratch marks adjacent to the rupture. It is likely vessel characteristics, although unknown, contributed to the reported event as evidenced by device analysis. The balloon material near the rupture appears to have been torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon. According to the instructions for use, although this is not intended as a mitigation, ¿prior to use, the device should be examined to verify functionality and integrity, and ensure that its size is suitable for the specific procedure. Do not exceed the rated burst pressure recommended on the label. The rated burst pressure is based on the results of in-vitro testing. At least 99. 9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure. Use of a pressure-monitoring device is recommended to prevent over-pressurization. Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline). Never use air or any gaseous medium to inflate the balloon. ¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event. Therefore, no corrective or preventive action will be taken at this time.
 
Event Description
As reported, during a procedure the balloon of a 4mm x 30mm 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter would not inflate. There was no reported injury to the patient. Additional information was requested but was not provided, and the device will be returned for evaluation. Addendum: product evaluation revealed a rupture to the mid-portion of the balloon.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAVIATOR PLUS .014 4.0X30 142CM
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 Key13964359
MDR Text Key291635709
Report Number9616099-2022-05494
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
Report Date 03/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4244030W
Device Lot Number82186614
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-