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

Model Number	4244030W
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, when the aviator plus.014 4.0x30 142cm balloon catheter was used in the patient's body, the balloon was leaked, so result in the balloon can not be expanded.There was no patient injury.
Additional Manufacturer Narrative
During inflation, the aviator plus.014 4.0x30 142cm balloon catheter was used in the patient's body, and the balloon was leaking, which resulted in the balloon not expanding.The device was replaced with another aviator and the procedure was completed successfully there was no patient injury.The target lesion was seventy percent stenosed.There was no difficulty inflating the balloon during prep.There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The contrast media used during the procedure was iodixanol with a contrast to saline ratio of one to three.The inflation device used was successfully used with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The product was removed intact (in one piece) from the patient.One non-sterile aviator plus.014 4.0x30 142cm was received coiled inside a plastic bag.The balloon was already inflated.No other anomalies were noted in the returned device.Leak test was performed, and no leakage was observed in the balloon during test.A device history record (dhr) review of lot 17616870 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage¿ was not confirmed through analysis since the device passed functional testing.The cause of the balloon leakage reported could not be conclusively determined during the analysis.Based on the limited information available for review, concomitant device factors and handling factors likely contributed to the leakage experienced by the customer since the device had no leakage noted.According to the instructions for use, which is not intended as a mitigation, ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.Attach a 3-way stopcock to the inflation port, which is marked ¿balloon¿.Attach a partially filled syringe with heparinized saline to the stopcock, open the stopcock to the balloon and induce negative pressure.Hold the syringe and proximal end of the catheter above the distal end of the catheter, and hold the balloon vertically with the balloon tip pointing down.While maintaining negative pressure close the stopcock to the inflation port.Remove the syringe and purge the air.To ensure air contained in the balloon and inflation lumen is removed, apply negative pressure twice as instructed.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: AVIATOR PLUS .014 4.0X30 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 32575 ; EI 32575
• MDR Report Key: 7293618
• Report Number: 9616099-2018-01934
• Device Sequence Number: 135163
• Product Code: LIT
• UDI-Device Identifier: 20705032005750
• UDI-Public: 20705032005750
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 4244030W
• Device Catalogue Number: 4244030W
• Device Lot Number: 17616870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Distributor Facility Aware Date: 01/26/2018
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 02/24/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 65