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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 6.0X20 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL AVIATOR PLUS .014 6.0X20 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4246020W
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/26/2019
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17623155 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

During a carotid artery stent implantation, a. 014 6. 0x20 142cm aviator plus percutaneous transluminal angioplasty (pta)balloon catheter was attempted to be used for post-dilatation but it was found that there was a pinhole rupture at the tip of the balloon. The hole was noted after the packaging was opened, and the device was flushed. The device had been connected to the negative pressure pump. The device was not used and the procedure was completed using another balloon catheter. There was no reported patient injury. There were no difficulties removing the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover. There were no kinks or other damages noted prior to use. Iopamidol contrast media was used with a1:1, contrast to saline ratio. A non-cordis indeflator was used and it was used successfully with the other devices. Other additional procedural details were requested but were unknown.

 
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Brand NameAVIATOR PLUS .014 6.0X20 142CM
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9511506
MDR Text Key199695932
Report Number9616099-2019-03427
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK071189
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,Followup
Report Date 01/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/23/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2019
Device MODEL Number4246020W
Device Catalogue Number4246020W
Device LOT Number17623155
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/27/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/27/2017
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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