MAUDE Adverse Event Report: CORDIS CASHEL SABER 5MM4CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48005004X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: the balloon of a 5mm x 4cm x 150 saber percutaneous transluminal angioplasty (pta) was used; however, it ruptured within its nominal pressure.There was no reported patient injury.The lesion was the superficial femoral artery (sfa) with severe calcification, moderate tortuosity with 99% stenosis.A contralateral approached was made.The device was not used for a chronic total occlusion (total occlusion >3 months).The procedure was completed using a non-cordis balloon catheter and hemostasis was achieved by manual pressure.The device was stored and handled per the instructions for use (ifu).The device was prepped normally by (maintaining negative pressure) according to the ifu.There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, or through the guide catheter.This was endovascular therapy (evt) case.There was no difficulty advancing the balloon catheter through the vessel.There was some difficulty crossing the lesion.The catheter was never in an acute bend.The product was removed intact (in one piece) from the patient.The product was not returned for analysis as it was discarded due to suspicious infectious disease.A product history record (phr) review of lot 17630609 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 of severe calcification with stenosis may have contributed to the reported event, as calcification is known to damage balloon material.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and event reported.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 information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.
Event or Problem Description
As reported, the balloon of a 5 mm x 4 cm x 150 saber percutaneous transluminal angioplasty (pta) was used however, it ruptured within its nominal pressure.The procedure was completed using a non-cordis balloon catheter and hemostasis was achieved by manual pressure.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).The device was prepped according to the ifu.The device was prepped normally by maintaining negative pressure.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.This was endovascular therapy (evt) case.The lesion was the superficial femoral artery (sfa) with severe calcification, moderate tortuosity with 99% stenosis.A contralateral approached was made.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty advancing the balloon catheter through the vessel.There was some difficulty crossing the lesion.The catheter was never in an acute bend.The product was removed intact (in one piece) from the patient.The device will not be returned as it was discarded due to suspicious infection disease.

• Brand Name: SABER 5MM4CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9617023
• Report Number: 9616099-2020-03500
• Device Sequence Number: 2738836
• Product Code: LIT
• UDI-Device Identifier: 20705032069530
• UDI-Public: 20705032069530
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2020

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: 12/31/2019
• Device Model Number: 48005004X
• Device Catalogue Number: 48005004X
• Device Lot Number: 17630609
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/25/2019
• Initial Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1