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

Model Number	4244030W
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device will be returned for testing and evaluation.  additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the aviator plus (.014 4.0x30 142cm) balloon rupture at 9 atmospheres (atm).There was no reported patient injury.The product will be returned for analysis.
Additional Manufacturer Narrative
(b)(6).Complaint conclusion: the aviator plus (.014 4.0x30 142cm) balloon ruptured at nine atmospheres (9atm).There was no reported patient injury.The product was returned for analysis.One non-sterile aviator plus.014 4.0 x 30 142cm balloon catheter was returned.Per visual analysis, the balloon was coiled inside a plastic bag and had been previously inflated/deflated.A cracked condition was observed on the shaft at 116 cm from the strain relief.No other anomalies were observed.A leak test was performed and leakage due to a burst condition on the distal balloon area was noted.Per sem analysis, the balloon leakage was caused by a rupture on the balloon surface.The external surface presented evidence of micro tears and scratch marks adjacent to the rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.A product history record (phr) review of lot 17689239 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp¿ and ¿body/shaft- cracked¿ was confirmed through analysis of the returned device.The exact cause could not be determined; however, analysis revealed micro tears and scratch marks adjacent to the rupture.It is likely the balloon material encountered a sharp object, for example calcium in the vessel, as it is known that calcification may damage balloon material.There is no additional information regarding patient, lesion or procedural characteristics regarding this event.With the paucity of information available it is difficult to draw a clinical conclusion between the device and the reported event.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.Caution: if strong resistance is met during advancement or withdrawal of the balloon catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.Note: if the balloon cannot be withdrawn through the guiding catheter, withdraw the balloon catheter and guiding catheter as a single unit.¿ neither the phr 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.
Additional Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

• Brand Name: AVIATOR PLUS .014 4.0X30 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8581968
• Report Number: 9616099-2019-02898
• Device Sequence Number: 16877731
• Product Code: LIT
• UDI-Device Identifier: 20705032005750
• UDI-Public: 20705032005750
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K071189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2019

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: 05/31/2020
• Device Model Number: 4244030W
• Device Catalogue Number: 4244030W
• Device Lot Number: 17689239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/15/2019; 06/13/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/07/2019; 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1