MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 5.5X15 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4245515W
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: an aviator plus balloon catheter (.014 5.5 x 15 x 142cm) was delivered to the lesion in the renal artery; however, it ruptured at fourteen atmospheres (14atm) due to severe calcification.There was no patient injury reported.The product was not returned for analysis.A product history record (phr) review of lot 17594141 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 of severe calcification 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, an aviator plus balloon catheter (.014 5.5x15 142cm) was delivered to the lesion in the renal artery, however, it ruptured at 14 atmospheres (atms) due to severe calcification.There was no patient injury reported.The device was clinically used and will not be returned for analysis.

• Brand Name: AVIATOR PLUS .014 5.5X15 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8555614
• Report Number: 9616099-2019-02878
• Device Sequence Number: 19375321
• Product Code: LIT
• UDI-Device Identifier: 20705032005859
• UDI-Public: 20705032005859
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2019

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: 08/31/2019
• Device Model Number: 4245515W
• Device Catalogue Number: 4245515W
• Device Lot Number: 17594141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1