MAUDE Adverse Event Report: CORDIS DE MEXICO SABER RX3MM4CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51003004L

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion:  during the prepping of a saber rx balloon catheter (3mm x 4cm155cm), it was reported that the balloon did not inflate when some pressure was applied with an indeflator.The same issue occurred three times.Moreover, a leakage from the joint of the hub and the shaft was confirmed.Therefore it was replaced with a new saber of the same size.The procedure was finished successfully and there was no patient injury.There was no patient injury as the device was not clinically used.There were no anomalies noted when the device was taken out of the package.It is unknown if the device was resterilized.The device was prepped following ifu (instructions for use) instructions.No additional information is available.The product was not returned for analysis.A device history record (dhr) review of lot 17276549 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) leakage - during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural or handling factors may have contributed to the reported event as excessive tightening or cross-threading at the luer hub may result in leakage at the hub.According to the instructions for use ¿preparation: attach a 3-way stopcock to the inflation port, which is marked ¿balloon¿.Attach a partially filled syringe with heparinized saline to the stopcock, open the stopcock to the balloon and induce negative pressure.Hold the syringe and proximal end of the catheter above the distal end of the catheter, and hold the balloon vertically with the balloon tip pointing down.While maintaining negative pressure close the stopcock to the inflation port.Remove the syringe and purge the air.To ensure air contained in the balloon and inflation lumen is removed, apply negative pressure twice as instructed and repeat steps 2-4.Without twisting, slide the forming tube off the balloon.Prepare an angioplasty inflation system with a 50% solution of contrast medium in sterile saline or similar solution.Purge the air from the inflation device.Connect the inflation device to the 3-way stopcock that is connected to the catheter inflation port, open the stopcock to the catheter and slowly fill the inflation lumen and the balloon will slowly fill with diluted contrast medium.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ however the ifu is not a mitigation for risk factors.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 at this time.

Event Description

During the prepping of a saber rx balloon catheter (3mm4cm155), it was reported that the balloon did not inflate when some pressure was applied with an indeflator.The same issue occurred three times. moreover, a leakage from its joint of the hub and the shaft was confirmed.Therefore it was replaced with a new saber of the same size.  the procedure was finished successfully and there was no patient injury.There was no patient injury as the device was not clinically used.The product will not be returned for analysis. there were no anomalies noted when the device was taken out of the package.  it is unknown if the device was resterilized.  the device was prepped following ifu instructions.  no additional information is available.

• Brand Name: SABER RX3MM4CM155
• 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 avenue; miami lakes, FL 33014
• MDR Report Key: 6386898
• MDR Text Key: 69388182
• Report Number: 9616099-2017-00945
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 51003004L
• Device Catalogue Number: 51003004L
• Device Lot Number: 17276549
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/10/2017
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2015
• 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