MAUDE Adverse Event Report: CORDIS CASHEL SABER 4MM30CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 48004030X

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 4 x 300mm saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 13 atm (atmospheres) while treating a lesion in the popliteal and distal superficial artery (sfa).There was no patient injury reported.The device will not be returned for evaluation.The device was stored in the cath lab for approximately 12 months as per instructions for use (ifu).The device was stored, handled and prepped as per ifu.The device was prepped normally (i.E.Maintained negative pressure).There was little tortuosity noted on the vessel.It had 90% stenosis.The device was not used for a chronic total occlusion.There was no difficulty in removing the stylet or any sterile packaging components.There was no difficulty in removing product from the hoop.There was no difficulty in removing the protective balloon cover.There were no kinks or other damages noted prior to inserting the product into the patient.A non-cordis contrast media was used and the contrast to saline ratio is 50/50.They used a non-cordis inflation device (indeflator/syringe) and the same indeflator was used successfully with other devices.There was no resistance/friction felt while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction felt when inserting the balloon through the guide catheter.There was no unusual force used at any time during the procedure.The device was removed intact (in one piece) from the patient.The balloon was delivered to the target lesion without incident and there was no visible calcium.The balloon was removed from the patient without complication.The procedure was completed using a new balloon catheter.Other additional procedural details were requested but were unknown.

Manufacturer Narrative

A saber 4mm x 30mm 150cm percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 13 atm (atmospheres) while treating a lesion in the popliteal and distal superficial artery (sfa).There was little tortuosity noted on the vessel and it had 90% stenosis.The device was not used for a chronic total occlusion.The balloon was delivered to the target lesion without incident and there was no visible calcium.The balloon was removed from the patient without complication.There was no patient injury reported.The device was stored in the cath lab for approximately 12 months as per instructions for use (ifu).The device was stored, handled and prepped normally (i.E.Maintained negative pressure) as per ifu.There was no difficulty in removing the product from the hoop, the protective balloon cover, the stylet or any sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.Non-cordis contrast media was used and the contrast to saline ratio was 50/50.A non-cordis inflation device was used (indeflator/syringe) and the same indeflator was used successfully with other devices.There was no resistance/friction felt while inserting the balloon through the rotating hemostatic valve or through the guide catheter.There was no unusual force used at any time during the procedure.The device was removed intact (in one piece) from the patient.The procedure was completed using a new balloon catheter.Other additional procedural details were requested but were unknown.The device was not returned for analysis.A product history record (phr) review of lot 82163369 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.It is likely procedural factors and vessel characteristics of mild tortuosity and 90% stenosis may have contributed to the reported event as the potential presence of calcification is known to cause damage to balloons.However, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the 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/preventive action will be taken at this time.

• Brand Name: SABER 4MM30CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9458777
• MDR Text Key: 175896290
• Report Number: 9616099-2019-03400
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069509
• UDI-Public: 20705032069509
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 48004030X
• Device Lot Number: 82163369
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK NEW BALLOON