MAUDE Adverse Event Report: CORDIS CASHEL SABER 4MM2CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48004002S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).During use, a saber percutaneous transluminal angioplasty (pta) balloon catheter (bc) was delivered to the lesion and inflated; however, it ruptured at eight atmospheres (atm).There was no patient injury.Therefore, the saber pta balloon was replaced with a same size new competitor's balloon catheter which inflated.The procedure was completed with a drug-coated balloon.The product was not returned for analysis.A product history record (phr) review of lot 17539119 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.Vessel characteristics may have contributed to the reported event as the presence of calcification may cause rupture to the balloon material.According to the warnings in the safety information in the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.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.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ neither the phr nor the limited 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 (bc) was delivered to the lesion and inflated; however it ruptured at eight atmosphere (8 atm).There was no patient injury.Therefore the saber pta balloon was replaced with a same size new competitor's balloon catheter which inflated.The procedure was completed with a drug-coated balloon.The device will not be returned for analysis due to infectious disease.
Additional Manufacturer Narrative
During use, a saber percutaneous transluminal angioplasty (pta) balloon catheter (bc) was delivered to the lesion and inflated; however, it ruptured at eight atmospheres (atm).There was no patient injury.Therefore, the saber pta balloon was replaced with a same size new competitor's balloon catheter which inflated.The procedure was completed with a drug-coated balloon.The product was not returned for analysis.A product history record (phr) review of lot 17539119 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.Vessel characteristics may have contributed to the reported event as the presence of calcification may cause rupture to the balloon material.According to the warnings in the safety information in the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.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.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ neither the phr nor the limited 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 4MM2CM 90
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 00000 ; EI 00000
• MDR Report Key: 8306592
• Report Number: 9616099-2019-02687
• Device Sequence Number: 16156580
• Product Code: LIT
• UDI-Device Identifier: 20705032069820
• UDI-Public: 20705032069820
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

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: 06/30/2019
• Device Model Number: 48004002S
• Device Catalogue Number: 48004002S
• Device Lot Number: 17539119
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1