MAUDE Adverse Event Report: CORDIS CASHEL SABER 2MM4CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48002004X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a 2x40mm saber balloon catheter ruptured at three atmospheres (3 atm).Therefore, the balloon was replaced with a new saber balloon catheter and the procedure was completed successfully.There was no reported patient injury.The target lesion was the left superficial femoral artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was 100 % (chronic total occlusion [cto]).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.A guidewire crossed the lesion and a saber was delivered for an inflation however it ruptured at 3 atm.The product was 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 17232797 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 (peripheral)¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Based on the information available for review, vessel characteristics (cto) may have contributed to the reported event.According to the instructions for use, ¿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.¿ 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.
Event or Problem Description
It was reported that a 2x40mm saber balloon catheter ruptured at three atmospheres (3 atm).Therefore, the balloon was replaced with a new saber balloon catheter and the procedure was completed successfully.There was no reported patient injury.The target lesion was the left superficial femoral artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was 100 % (chronic total occlusion [cto]).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.A guidewire crossed the lesion and a saber was delivered for an inflation however it ruptured at 3 atm.The product was removed intact (in one piece) from the patient.No other information was provided.

• Brand Name: SABER 2MM4CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tp ; EI
• MDR Report Key: 6560205
• Report Number: 9616099-2017-01087
• Device Sequence Number: 13679271
• Product Code: LIT
• UDI-Device Identifier: 20705032069899
• UDI-Public: 20705032069899
• 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: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2017

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: 03/31/2018
• Device Model Number: 48002004X
• Device Catalogue Number: 48002004X
• Device Lot Number: 17232797
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1