MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2MM20CM 150 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER

Model Number N/A

Device Problems Material Frayed (1262); Catheter (3038); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2019

Event Type  Malfunction  

Manufacturer Narrative

While attempting to advance the saber balloon catheter (2mm x 20cm x 150cm) over an unknown guidewire, the wire got stuck and did not come out of the hub. Another balloon was used to complete the procedure and there was no patient injury. During preparation, 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 or other damages noted to the device. The device was prepped normally and was not inserted into the patient. A video of the attempt to insert the device was received which shows the wire could not be inserted into hub. The event reported did not occur inside the patient but occurred during balloon preparation for the procedure, while putting the balloon over the wire. The product was never inside of the patient. There was no difficulty removing the product from the wire and no excessive force needed to remove the balloon. It removed from the wire by hand. After it was removed from the wire, the physician tried to insert the wire 2-3 times unsuccessfully. The device was returned for analysis. A non-sterile saber 2mm x 20cm x 150 pta balloon catheter was returned. Per visual analysis, the catheter was coiled inside a plastic bag, the body shaft was bent at 29. 8cm from the strain relief. The guidewire lumen appears to be wrinkled inside the hub area. Functional analysis was performed, a lab sample syringe filled with water was attached to the luer hub of the catheter and resistance was noted upon flushing. An. 018¿ guide wire sample was introduced into the guide wire lumen of the saber balloon via hub and resistance was observed. However, the guidewire did pass through the area of resistance. Per sem analysis, the damage to the guidewire lumen was caused by a rupture on the guidewire lumen. The outer surface of the guidewire lumen revealed evidence of peeled off material adjacent to the lumen rupture. The inner surface revealed a puncture hole, tension and scratch marks adjacent to the lumen rupture. No other anomalies were found during the sem analysis. A product history record (phr) review of lot 82157428 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿guidewire lumen resistance/friction¿ was confirmed through analysis of the returned device. The exact cause could not be determined. Per device analysis, the guidewire lumen revealed a rupture with the inner surface noted to have a puncture hole, tension and scratch marks adjacent to the rupture. This type of damage is commonly caused during the interaction of the guidewire lumen material with a sharp object or mechanical damage. It seems the guidewire lumen material near the rupture was torn with a sharp object from the inside of the lumen. Therefore, it likely that handling of the device and forceful prepping damaged the guidewire lumen since the device was never used inside the patient. Extreme care must be taken when prepping the balloon catheters in order to prevent this type of damage from occurring. According to the instructions for use, which are not intended to mitigate risk, ¿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. ¿ 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, while attempting to advance the saber balloon catheter (2mm20cm 150) over a 0. 018¿ terumo advantage guidewire, the wire got stuck and did not come out of the hub. Another balloon was used to complete the procedure and there was no patient injury. The device was returned for analysis. Analysis indicates rupture on the guidewire lumen and the outer surface of the guidewire lumen presented evidence of peeled off material near to the lumen rupture. During preparation, there was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover and 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 into the patient. The device also prepped normally and was not inserted into the patient. A video of the attempt to insert the device was received which shows the wire could not be inserted into hub. The event reported did not occur inside the patient but occurred during balloon preparation for the procedure, while putting the balloon over the wire. The product was never inside of the patient. There was no difficulty removing the product from the wire and no excessive force needed to remove the balloon. It removed from the wire by hand. After it was removed from the wire, the physician tried to insert the wire 2-3 times unsuccessfully.

• Brand Name: SABER 2MM20CM 150
• Type of Device: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9105866
• MDR Text Key: 202872035
• Report Number: 9616099-2019-03219
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: IS
• 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: 09/23/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/23/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: N/A
• Device Catalogue Number: 48002020X
• Device LOT Number: 82157428
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 08/09/2018
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial