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

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

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.

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.

• Brand Name: AVIATOR PLUS .014 5.5X20 142CM
• Type of Device: CATHETER, 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 Key: 7154450
• MDR Text Key: 96120234
• Report Number: 9616099-2017-01743
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 4245520W
• Device Catalogue Number: 4245520W
• Device Lot Number: 17458065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1