MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 5.0X40 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4245040W
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This was an endovascular treatment (evt) case, an aviator plus (.014 5.0 x 40 x 142cm) was used for a pre-dilatation; however, it ruptured at its nominal pressure.There were no reported patient injuries.It was replaced with a new balloon catheter and the procedure was completed.The product was not returned for analysis.A product history record (phr) review of lot 17535543 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¿ 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, vessel characteristics and procedural factors 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
As reported, this was an endovascular treatment (evt) case, an aviator plus 014 5.0x40 142cm was used for a pre-dilatation, however it ruptured at its nominal pressure.There were no reported patient injuries.Therefore it was replaced with a new balloon catheter and the procedure was completed.Additional procedural details were requested but are unknown.
Additional Manufacturer Narrative
Section b5: addendum for additional information obtained:the device was stored, handled and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.The balloon catheter was removed easily and intact from the patient.This is an updated complaint conclusion due to additional information received on july 16, 2019.This was an endovascular treatment (evt) case, an aviator plus (.014 5.0 x 40 x 142cm) was used for a pre-dilatation; however, it ruptured at its nominal pressure.There were no reported patient injuries.It was replaced with a new balloon catheter and the procedure was completed.The device was stored, handled and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.The balloon catheter was removed easily and intact from the patient.The product was not returned for analysis.A product history record (phr) review of lot 17535543 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¿ 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, vessel characteristics and procedural factors 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 5.0X40 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8790688
• Report Number: 9616099-2019-03077
• Device Sequence Number: 14113070
• Product Code: LIT
• UDI-Device Identifier: 20705032005842
• UDI-Public: 20705032005842
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/26/2019

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: 06/30/2019
• Device Catalogue Number: 4245040W
• Device Lot Number: 17535543
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BALLOON CATHETER