MAUDE Adverse Event Report: CORDIS CASHEL SABER 6MM10CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 48006010S

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

The 6 mm x 10 mm 90 saber percutaneous transluminal angioplasty (pta) was used however, it ruptured within its normal pressure.There was no reported patient injury.The target lesion was the calcaneal vein with moderate vessel tortuosity and little calcification.The device was not used for chronic total occlusion.The device was stored in the cath lab shelf properly.The device was stored and handled per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure per 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.The same indeflator was used successfully with other devices.The balloon ruptured at seven atmospheres (atm).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 another device.There were no kinks or other damages noted prior to inserting the product into the patient.The product was not returned for analysis due to suspicious infectious disease.A product history record (phr) review of lot 17652789 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 tortuosity and calcification may have contributed to the reported event.However, as clearly stated in the event description the device was used off label in the calcaneal vein.This may have been a contributing factor to the event reported as this is contraindicated in the ifu.According to the indications in the instructions for use, which are not intended to mitigate risk, ¿the saber pta catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.¿ 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 Description

As reported, the 6 mm x 10 mm 90 saber percutaneous transluminal angioplasty (pta) was used however, it ruptured within its normal pressure.The procedure was completed using another device, but the agent did not answer the device details.There was no reported patient injury.The device was stored in the cath lab shelf properly.The device was stored and handled per the instructions for use (ifu).The device was prepped per the ifu.The device was prepped normally by maintain 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.This was a shunt percutaneous transluminal angioplasty (pta) case.The target lesion was the calcaneal vein with moderate vessel tortuosity and little calcification.The device was not used for chronic total occlusion.The same indeflator was used successfully with other devices.The balloon ruptured at seven atmospheres (atm).There was no unusual force used at any time during the procedure.The device was removed intact (in one piece) from the patient.There were no kinks or other damages noted prior to inserting the product into the patient.The device will not be returned for analysis due to suspicious infectious disease.

• Brand Name: SABER 6MM10CM 90
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co.; tipperary ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co.; tipperary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9495340
• MDR Text Key: 199695448
• Report Number: 9616099-2019-03417
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 48006010S
• Device Lot Number: 17652789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1