MAUDE Adverse Event Report: CORDIS CASHEL SABER 2MM2CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48002002S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6): concomitant medical products and therapy dates (exclude treatment of event): guidewire (treasure floppy, asahi intecc) catheter (cxi, cook).During use, it was reported that the 2x20mm 90cm saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured at eight atmosphere after a competitor's guidewire and guide catheter was inserted in the patient.The saber pta balloon catheter was replaced with a new saberx (2x20mm) and the patient was confirmed to have good blood-flow and the procedure was completed.There was no patient injury.The lesion was the right below the knee which was slightly calcified, not tortuous with eighty percent stenosis.There were no difficulty inflating the balloon during prep.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.A competitor's contrast media and inflation device was used.The inflation device was successfully used with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.The catheter has never been in an acute bend.The product removed intact (in one piece) from the patient.No other information was provided.The device was not returned for analysis.A device history record (dhr) review of lot 17514481 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, lesion characteristics (slight calcification) and procedural/handling factors may have contributed to the reported event since calcified/resistant lesions can 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 result of in vitro testing.At least 99.9% of the balloons (with a 95% confidence level) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.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 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
During use, it was reported that the saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured at eight atmosphere after a competitor's guidewire and guide catheter was inserted in the patient.There was no patient injury.The saber pta balloon catheter was replaced with a new saber x (2mm*20mm) and the patient was confirmed to have good blood-flow and the procedure was completed.The lesion was the right below the knee which was slightly calcified, not tortuous with eighty percent stenosis.There were no difficulty inflating the balloon during prep.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.A competitor's contrast media and inflation device was used.The inflation device was successfully used with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.The catheter has never been in an acute bend.The product removed intact (in one piece) from the patient.The device is not available for analysis.No other information was provided.

• Brand Name: SABER 2MM2CM 90
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 00000 ; EI 00000
• MDR Report Key: 8075681
• Report Number: 9616099-2018-02529
• Device Sequence Number: 13994786
• Product Code: LIT
• UDI-Device Identifier: 20705032069769
• UDI-Public: 20705032069769
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2018

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: 05/31/2019
• Device Model Number: 48002002S
• Device Catalogue Number: 48002002S
• Device Lot Number: 17514481
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1