MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 4.0X20 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4244020W
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During a percutaneous transluminal renal angioplasty, it was reported that the aviator plus balloon catheter was delivered to the lesion; however, it ruptured around its nominal pressure during initial inflation.
Additional Manufacturer Narrative
Additional information was received via email and (description of event) was updated in the first paragraph below.During a percutaneous transluminal renal angioplasty, it was reported that the 4x20mm 142cm.014 aviator plus balloon catheter was delivered to the lesion; however, it ruptured around its nominal pressure during initial inflation.No other information was provided.There was no difficulty removing the product from the hoop.The product was removed intact from the patient.Additional procedural details were requested but are unknown.The device was not returned for analysis.A device history record (dhr) review of lot 17712403 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 of the burst could not be determined.Based on the limited information available for review, vessel characteristics (although not provided) and procedural/handling factors may have contributed to the reported event since calcified/resistant lesions can damage the balloon.According to the instructions for use, which is not intended as a mitigation, ¿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.Do not exceed the rated burst pressure recommended on the label.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ neither the dhr 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
During a percutaneous transluminal renal angioplasty, it was reported that the 4x20mm 142cm.014 aviator plus balloon catheter was delivered to the lesion; however, it ruptured around its nominal pressure during initial inflation.No other information was provided.The device was not returned for analysis.A device history record (dhr) review of lot 17712403 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 of the burst could not be determined.Based on the limited information available for review, vessel characteristics (although not provided) and procedural/handling factors may have contributed to the reported event since calcified/resistant lesions can damage the balloon.According to the instructions for use, which is not intended as a mitigation, ¿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.Do not exceed the rated burst pressure recommended on the label.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ neither the dhr 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 4.0X20 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 00000 ; EI 00000
• MDR Report Key: 7700560
• Report Number: 9616099-2018-02255
• Device Sequence Number: 16420839
• Product Code: LIT
• UDI-Device Identifier: 20705032005743
• UDI-Public: 20705032005743
• 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: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2018

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: 07/31/2020
• Device Model Number: 4244020W
• Device Catalogue Number: 4244020W
• Device Lot Number: 17712403
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 09/23/2018; 10/02/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/27/2018; 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1