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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 5.5X20 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL AVIATOR PLUS .014 5.5X20 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4245520W
Device Problems Material Frayed (1262); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2017
Event Type  malfunction  
Manufacturer Narrative
Complaint conclusion: as reported, an aviator plus (. 014 5. 5x20 142cm) could not cross the lesion and the distal end got frayed. A competitor guidewire could not cross the lesion and the distal end was damaged. Therefore, both devices were replaced with new devices to complete the procedure. No anomalies were confirmed during preparation. The procedure was completed successfully. There was no reported patient injury. The patient¿s information was unknown. The target lesion was unknown. The patient¿s vessel level of tortuousness and calcification was unknown. The rate of stenosis was unknown. The intended procedure was a below the knee (btk) and renal procedure. The access site was antegrade for btk and radial for renal. The target lesions were btk and the renal artery. The product was stored, handled, inspected and prepped according to the ifu. The product was prepped per the instructions for use (ifu). The product, or any of the other devices used with it, had not been resterilized. Excess force was not used during insertion. The device did not pass through any acute bends or tortuosity. There was no difficulty tracking through the vasculature. The device was removed intact. The device was not returned for analysis. A device history record (dhr) review of lot 17458065 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿pta/ptca system failure to cross¿ and ¿distal tip frayed/split/torn¿ could not be confirmed as the device was not returned for analysis. The exact cause of the burst could not be determined. Based on the limited information available for review, vessel characteristics (calcified) or concomitant device factors may have contributed to the reported event as calcification/resistant lesions may cause damage to a balloon. Difficulty crossing a product through an anatomical structure is a known procedural occurrence. This type of difficulty occurring during the clinical use of the device is usually addressed by modification in technique or substitution with another device. Crossing difficulty is most commonly related to the patient¿s anatomy, vessel characteristics, operator¿s technique and appropriate device selection. As warned in the instructions for safety, which is not intended as a mitigation, ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding. Prior to use, the device should be examined to verify functionality and integrity, and ensure that its size is suitable for the specific procedure. ¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event. Therefore, no corrective/preventive action will be taken at this time.
 
Event Description
As reported, an aviator plus (. 014 5. 5x20 142cm) was inserted, but could not cross the lesion and the distal end got frayed. A chevalier tapered 30 could not cross the lesion and the distal end was damaged. Therefore, both devices were replaced with new devices to complete the procedure. No anomalies were confirmed during preparation. The procedure was completed successfully. There was no reported patient injury. The products were clinically used and will not be returned for analysis. The patient¿s information was unknown. The target lesion was unknown. The patient¿s vessel level of tortuousness and calcification was unknown. The rate of stenosis was unknown. The intended procedure was a btk and renal procedure. The access site was antegrade for btk and radial for renal. The target lesions were btk and the renal artery. The product was stored, handled, inspected and prepped according to the ifu. The product was prepped per the instructions for use (ifu). The product, or any of the other devices used with it, had not been resterilized. Excess force was not used during insertion. The device did not pass through any acute bends or tortuosity. There was no difficulty tracking through the vasculature. The device was removed intact.
 
Manufacturer Narrative
A device history record (dhr) review of lot 17458065 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, an aviator plus (. 014 5. 5x20 142cm) was inserted, but could not cross the lesion and the distal end got frayed. A chevalier tapered 30 could not cross the lesion and the distal end was damaged. Therefore, both devices were replaced with new devices to complete the procedure. No anomalies were confirmed during preparation. The procedure was completed successfully. There was no reported patient injury. The products were clinically used and will not be returned for analysis. The patient¿s information was unknown. The target lesion was unknown. The patient¿s vessel level of tortuousness and calcification was unknown. The rate of stenosis was unknown.
 
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Brand NameAVIATOR PLUS .014 5.5X20 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
MDR Report Key7154450
MDR Text Key274488402
Report Number9616099-2017-01743
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Model Number4245520W
Device Catalogue Number4245520W
Device Lot Number17458065
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 Received01/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2016
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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