MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX8MM2CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51008002L

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

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

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, an 8mm x 2cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter could not cross the lesion.It was then removed from the patient¿s body, and it was confirmed that the distal end of the tip was frayed.There was no reported patient injury.Prior to that, an unknown wire crossed the lesion.The procedure was an endovascular therapy case (evt) of the superficial femoral artery (sfa).The sfa had mild calcification, mild angulation, and mild tortuosity.There was 90% stenosis, and it was not a cto.The device was not resterilized.The device was stored and prepped as per the instructions for use (ifu).There were no anomalies noted when removed from the package nor during prep.The balloon did become caught in the lesion but there was no resistance met while withdrawing the device from the vessel.The balloon was not caught in a deployed stent.The procedure was completed using another unknown device.Other procedural details were requested but are unknown, unavailable, or not applicable.The device was not returned for evaluation as it was discarded in the hospital.A product history record (phr) review of lot 82182742 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported by the customer as ¿distal tip frayed/split/torn - in-patient¿ and ¿pta/ptca system failure to cross¿ could not be confirmed as the device was not returned for analysis.The exact cause cannot be determined.The lesion had mild calcification, mild angulation, and mild tortuosity with 90% stenosis which may have contributed to the frayed tip and difficulty crossing reported by the customer.It is likely vessel characteristics, procedural factors and handling of the catheter contributed to the events reported by the customer.Difficulty crossing a lesion, or an anatomical structure is a known procedural occurrence.Difficulty crossing a lesion has been investigated, and the consequences of crossing difficulty occurring during clinical use of the device are usually addressed by modification in technique or substitution with another device.Crossing difficulty is most commonly related to patient anatomy, operator technique and appropriate device selection.Therefore, based on the information available and without the return of the product for analysis, it is difficult to draw a clinical conclusion between the device and the reported events.According to 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.If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.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.¿ neither the phr review nor the product analysis suggests that the found damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

Event Description

As reported, an 8mm x 2cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter could not cross the lesion.It was then removed from the patient¿s body, and it was confirmed that the distal end of the tip was frayed.There was no reported patient injury.Prior that, an unknown wire crossed the lesion.The procedure was an endovascular therapy case (evt) of the superficial femoral artery (sfa).The sfa had mild calcification, mild angulation, and mild tortuosity.There was 90% stenosis and it was not a cto.The device was not resterilized.The device was stored and prepped as per the instructions for use (ifu).There were no anomalies noted when removed from the package nor during prep.The balloon did become caught in the lesion but there was no resistance met while withdrawing the device from the vessel.The balloon was not caught in a deployed stent.The procedure was completed using another unknown device.Other procedural details were requested but are unknown, unavailable, or not applicable.The device will not be returned for evaluation as it was discarded in the hospital.

• Brand Name: SABER RX8MM2CM155
• 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: 12768455
• MDR Text Key: 281761225
• Report Number: 9616099-2021-05041
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032075401
• UDI-Public: (01)20705032075401(17)221130(10)82182742
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 51008002L
• Device Catalogue Number: 51008002L
• Device Lot Number: 82182742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2019
• 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
• Treatment: UNKNOWN WIRE, UNKNOWN DEVICE