MAUDE Adverse Event Report: CORDIS CASHEL SABER 6MM4CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48006004X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.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
During use, it was reported that the saber balloon catheter ruptured at ten atmosphere (10 atm).There was no reported patient injury.The saber balloon was replaced with a same size new non cordis balloon catheter, a stent was then implanted and the procedure was completed successfully.A guidewire crossed the lesion and a saber balloon was delivered to the lesion for pre dilatation.However, it ruptured at approximately 10 atm during its initial inflation.The target lesion was the superficial femoral 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 not be returned for analysis.
Additional Manufacturer Narrative
During use, it was reported that the 6x40mm 150cm saber balloon catheter ruptured at approximately ten atmospheres (10 atm) during initial inflation.The saber balloon was replaced with a same size new non cordis balloon catheter, a stent was then implanted and the procedure was completed successfully.There was no reported patient injury.A guidewire crossed the lesion and a saber balloon was delivered to the lesion for pre-dilatation.The target lesion was the superficial femoral artery which was moderately tortuous and ninety-nine percent stenosis.There was no calcification.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 inflation device was used and it was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.The catheter was never in an acute bend.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 17594137 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 could not be determined.Based on the limited information available for review, vessel characteristics (99% stenosis and moderate tortuosity) may have contributed to the reported event since 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 (b)(4) 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.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: SABER 6MM4CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary ; EI
• MDR Report Key: 7273372
• Report Number: 9616099-2018-01881
• Device Sequence Number: 16173734
• Product Code: LIT
• UDI-Device Identifier: 20705032068175
• UDI-Public: 20705032068175
• 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,Followup
• Report Date (Section B): 03/20/2018

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: 08/31/2019
• Device Model Number: 48006004X
• Device Catalogue Number: 48006004X
• Device Lot Number: 17594137
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/18/2018
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER (STERLING, BOSTON SCIENTIFIC), UN