MAUDE Adverse Event Report: CORDIS CORPORATION SABER035 8MM2CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48008002N

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

As reported, the marker bands of a.035¿ 8mm x 2cm 80 saber percutaneous transluminal angioplasty (pta) balloon catheter lacks visibility.The procedure was completed normally, but with a poor visibility of the marker bands, having a negative impact on the accuracy of the balloon placement.There was no reported patient injury.In the receiving area, the saber was not exposed to long periods of sunlight.The humidity was not controlled in this room.The product was stored there for around 2 days before it was distributed to the cath lab.At any time prior to use in the cath lab, the device was not exposed to long periods of sunlight, high temperatures or increased humidity.The balloon cover/sheath and shipping stylet were removed separately.There was no damage noted to the product¿s packaging prior to opening.There were no anomalies noted when the device was removed from its packaging.There were no kinks noted on the device in the affected region.The intended procedure was an iliac procedure.The lesion was moderately calcified.There was no vessel tortuosity.The device was not used for a chronic total occlusion (total occlusion >3 months).The device was stored and handled per the instruction for use (ifu).There was no difficulty removing the product from the hoop.There was difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The device was prepped normally (i.E.Maintain negative pressure).An indeflator inflation device was used.The same indeflator was used successfully with other devices.There was resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The catheter was not torqued against resistance.The catheter was not re-shaped by the user.The product was removed intact (in one piece) from the patient.All the marker bands were accounted for after removal of the device.The device was not returned for analysis.A product history record (phr) review of lot 82195757 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿marker band-balloon catheters inadequate radiopacity, packaging/ pouch/box removal difficulty - protective balloon cover (balloon catheters) and pta/ptca system resistance/friction-outer body¿ could not be confirmed as the device was not returned for analysis.Nor were procedural images provided for review.The exact cause could not be determined.Possible causes of the reported events may include how the device was prepped, procedural factors such as fluoroscopy settings, and/or vessel characteristics.However, without the return of the device for analysis, or images of the reported inadequate radiopacity, it is not possible to draw a clinical conclusion between the device and the events reported by the customer.According to the device description in the safety information in the instructions for use ¿the cordis saber¿.035 percutaneous transluminal angioplasty (pta) catheter is a catheter with a distal inflatable balloon.Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.For balloon lengths 100mm or greater, the distal section will have two (2) adjacent marker bands and the proximal section will have one (1) marker band.For balloon lengths less than 100mm, the distal and proximal section will have each one (1) marker band.The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenosis.Saber balloons are coated with a hydrophilic material designed to increase lubricity throughout the lifetime of the device.The radiopaque marker bands indicate the stated nominal length of the balloon.Prepare an angioplasty inflation system with a 50% solution of contrast medium in sterile saline or similar solution.¿ 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 marker bands of a.035¿ 8mm x 2cm 80 saber percutaneous transluminal angioplasty (pta) balloon catheter lacks visibility.The procedure was completed normally, but with a poor visibility of the marker bands, having a negative impact on the accuracy of the balloon placement.There was no reported patient injury.In the receiving area, the saber was not exposed to long periods of sunlight.The humidity was not controlled in this room.The product was stored there for around 2 days before it was distributed to the cath lab.At any time prior to use in the cath lab, the device was not exposed to long periods of sunlight, high temperatures or increased humidity.The balloon cover/sheath and shipping stylet were removed separately.There was no damage noted to the product¿s packaging prior to opening.There were no anomalies noted when the device was removed from its packaging.There were no kinks noted on the device in the affected region.The intended procedure was an iliac procedure.The lesion was moderately calcified.There was no vessel tortuosity.The device was not used for a chronic total occlusion (total occlusion >3 months).The device was stored and handled per the instruction for use (ifu).There was no difficulty removing the product from the hoop.There was difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The device was prepped normally (i.E.Maintain negative pressure).An indeflator inflation device was used.The same indeflator was used successfully with other devices.There was resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The catheter was not torqued against resistance.The catheter was not re-shaped by the user.The product was removed intact (in one piece) from the patient.All the marker bands were accounted for after removal of the device.

• Brand Name: SABER035 8MM2CM 80
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 11273295
• MDR Text Key: 249258769
• Report Number: 9616099-2021-04230
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 48008002N
• Device Catalogue Number: 48008002N
• Device Lot Number: 82195757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2020
• 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