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

Catalog Number	4246020W
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Before use, there was leakage from the aviator plus.014 6.0 x 20 x 142cm balloon.There were no reported patient injuries.Additional procedural details were requested but are unknown.The product was not returned for analysis.A product history record (phr) review of lot 17762437 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Without the return of the product for analysis and with the paucity of information available, it is not possible to draw a clinical conclusion between the device and the reported event.However, procedural factors and handling may have contributed to 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.¿ 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.
Event or Problem Description
Before use, there was leakage from the aviator plus.014 6.0x20 142cm balloon.There were no reported patient injuries.Additional procedural details were requested but are unknown.
Additional Manufacturer Narrative
Additional procedural details were requested but are unknown.Before use, there was leakage from the aviator plus.014 6.0 x 20 x 142cm balloon.There were no reported patient injuries.The product was returned for analysis.One non-sterile aviator plus.014 6.0 x 20 x 142cm catheter was returned.Per visual analysis, the catheter was coiled inside a plastic bag, with the balloon deflated.No other anomalies were observed.Per functional analysis, a lab sample inflator/deflator filled with water was attached to the inflation lumen of the unit and successfully inflated.Neither leakage nor any other anomaly was observed during the inflation test.A product history record (phr) review of lot 17762437 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 by analysis of the returned device as functional analysis was performed successfully.The exact cause of the reported event could not be determined.The device performed as intended and with the paucity of information available, it is difficult to draw a clinical conclusion between the device and the reported event.However, procedural factors and handling of the device may have contributed to 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.¿ 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.

• Brand Name: AVIATOR PLUS .014 6.0X20 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8551990
• Report Number: 9616099-2019-02876
• Device Sequence Number: 313838
• Product Code: LIT
• UDI-Device Identifier: 20705032005903
• UDI-Public: 20705032005903
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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: 02/28/2021
• Device Catalogue Number: 4246020W
• Device Lot Number: 17762437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1