MAUDE Adverse Event Report: CORDIS CASHEL SABER 2MM20CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48002020X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).During inflation of the saber balloon catheter, it was reported that the balloon ruptured at below the rate burst pressure.There was no patient injury.The device could no longer be used and it was replaced with another device.Several attempts have been made by the local quality regulatory affairs (qra) to get further information unsuccessfully (i.E.The event date of each complaint).No other information was provided.The device was not returned for analysis.A device history record (dhr) could not be conducted as a lot number was not provided.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 as calcified/resistant lesions can damage 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.¿ without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore no corrective and preventive actions will be taken at this time.
Event or Problem Description
During inflation of the saber balloon catheter, it was reported that the balloon ruptured at below the rate burst pressure.There was no patient injury.The device could no longer be used and it was replaced with another device.

• Brand Name: SABER 2MM20CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 7504777
• Report Number: 9616099-2018-02124
• Device Sequence Number: 13957914
• Product Code: LIT
• UDI-Device Identifier: 20705032069219
• UDI-Public: 20705032069219
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

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 Model Number: 48002020X
• Device Catalogue Number: 48002020X
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1