MAUDE Adverse Event Report: CORDIS DE MEXICO SABER RX4MM15CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51004015L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

A saber percutaneous transluminal angioplasty (pta) balloon catheter (bc) ruptured at 6atm (six atmospheres).Initially, a non-cordis guiding catheter and a non-cordis guidewire crossed the lesion.The first saber balloon catheter was inflated and two smart control stents were implanted.Afterwards the saber balloon in question was delivered to the site to inflate and then ruptured at 6 atm.The balloon catheter was replaced with another saber balloon which was inflated up to 14 atm.The procedure was completed successfully.The patient¿s information was unknown.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification were unknown.The rate of stenosis was unknown.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).There were no anomalies noted when the device was taken out of the package.The device was prepped per the ifu.There were no anomalies noted during prep.The device prepped normally (i.E.Maintained 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 or other damages noted prior to inserting the product the product into the patient.The product was removed intact (in one piece) from the patient.Additional procedural details were requested but are unknown.The product was not returned for analysis.A device history record (dhr) review of lot 17402341 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.Procedural factors of inflating within a recently deployed stent may have contributed to the reported event.According to 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 the balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.(b)(4) 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 dhr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken.

Event Description

It was reported that a saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 6 atm.Initially, a non-cordis guiding catheter and a non-cordis guidewire crossed the lesion.The first saber balloon catheter was inflated and two smart control stents were implanted.Afterwards the saber balloon in question was delivered to the site to inflate and then ruptured at 6 atm.The balloon catheter was replaced with another saber balloon which was inflated up to 14 atm.The procedure was completed successfully.The patient¿s information was unknown.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification were unknown.The rate of stenosis was unknown.There was no reported patient injury.The product was clinically used and it will not be returned for analysis.The product was stored and handled according to the instructions for use (ifu).There were no anomalies noted when the device was taken out of the package.The device was prepped per the instructions for use (ifu).There were no anomalies noted during prep.The device prepped normally (i.E.Maintained 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 or other damages noted prior to inserting the product the product into the patient.The product was removed intact (in one piece) from the patient.Additional procedural details were requested but are unknown.

• Brand Name: SABER RX4MM15CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6216730
• MDR Text Key: 63691479
• Report Number: 9616099-2016-00824
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/30/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 51004015L
• Device Catalogue Number: 51004015L
• Device Lot Number: 17402341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/05/2016
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/30/2016
• Date Device Manufactured: 02/08/2016
• 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