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

Model Number	4246020W
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis but has not yet been received.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
It was reported that the aviator plus balloon catheter was delivered to inflate however, it ruptured.Therefore it was replaced with a new aviator plus (5 mm) and the procedure completed successfully.There was no reported patient injury.The target lesion was the pulmonary artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The product was clinically used and will be returned for analysis.
Additional Manufacturer Narrative
It was reported that the aviator plus balloon catheter was delivered to inflate however, it ruptured.Therefore it was replaced with a new aviator plus (5 mm) and the procedure completed successfully.There was no reported patient injury.The target lesion was the pulmonary artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The device prep normally.There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The product was removed intact (in one piece) from the patient.The device was not returned for analysis.A device history record (dhr) review of lot 17473017 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ 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 unknown) may have contributed to the reported event as calcification/resistant lesions may cause damage to a 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
This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
It was reported that the aviator plus balloon catheter was delivered to inflate however, it ruptured.Therefore it was replaced with a new aviator plus (5 mm) and the procedure completed successfully.There was no reported patient injury.The target lesion was the pulmonary artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The device prep normally.There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The product was removed intact (in one piece) from the patient.One non-sterile unit of aviator plus.014 6.0x20 142cm was received coiled inside a plastic bag.Per visual analysis, it was noticed that the balloon was previously inflated and deflated.No other issues were found.Leak test was performed and a leakage was observed on the balloon¿s distal section.The unit was sent to sem analysis in order to find the potential cause of the leakage on the received unit and results showed the leakage was caused by a rupture of the distal section of the balloon.The external surface of the balloon presented evidence of abrasions and scratch marks near the balloon rupture and it¿s very likely that the same factors that caused the abrasions and scratch marks could have also contributed to the rupture found on the received balloon.The internal surface of the balloon did not present any evidence of damages.No other anomalies were found during the analysis.A device history record (dhr) review of lot 17473017 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ was not confirmed due to the technical definition of a burst, however, a leakage was confirmed, which may appear to the user as a burst, through analysis of the returned device.The cause of the balloon rupture found could not be conclusively determined during the analysis.Based on the limited information available for review, vessel characteristics (although unknown) and procedural factors likely contributed to the ruptured condition reported as evidenced by the abrasions and scratch marks on the surface of 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 review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

• Brand Name: AVIATOR PLUS .014 6.0X20 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary ; EI
• MDR Report Key: 6825491
• Report Number: 9616099-2017-01366
• Device Sequence Number: 18947948
• Product Code: LIT
• UDI-Device Identifier: 20705032005903
• UDI-Public: 20705032005903
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/24/2017

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: 03/31/2019
• Device Model Number: 4246020W
• Device Catalogue Number: 4246020W
• Device Lot Number: 17473017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Distributor Facility Aware Date: 08/01/2017
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 09/26/2017; 09/28/2017; 10/19/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 09/27/2017; 09/29/2017; 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1