MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX5MM30CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number N/A

Device Problems Crack (1135); Material Frayed (1262); Material Split, Cut or Torn (4008)

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

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82204954 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, pre-dilation was done and the 5mm x 30cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was used but the distal tip got broken.The distal tip got kinked 1cm from the distal end.It was about to come off.Therefore, the device was replaced with another device with different lot number and the procedure continued.There was no reported patient injury.The device was stored and prepped as per the instructions for use (ifu).The device was not resterilized.There were no anomalies noted when removed from the package.There were no anomalies noted during prep.The lesion was the superficial femoral artery which had chronic total occlusion (cto).A contralateral approach was made with a 6f non-cordis guiding sheath.Other procedural details were requested but are unknown, unavailable, or not applicable.The device will be returned for analysis.

Event Description

As reported, pre-dilation was done and the 5mm x 30cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was used but the distal tip got broken.The distal tip got kinked 1cm from the distal end.It was about to come off.Therefore, the device was replaced with another device with different lot number and the procedure continued.There was no reported patient injury.The device was stored and prepped as per the instructions for use (ifu).The device was not resterilized.There were no anomalies noted when removed from the package.There were no anomalies noted during prep.The lesion was the superficial femoral artery which had chronic total occlusion (cto).A contralateral approach was made with a 6f non-cordis guiding sheath.Other procedural details were requested but are unknown, unavailable, or not applicable.The device will be returned for analysis.Addendum: during product analysis, a frayed/split/torn condition was observed on the distal tip.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, g3, g6, h1, h2, h3, h6, and h10.Complaint conclusion: as reported, pre-dilation was done and the 5mm x 30cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was used but the distal tip got broken.The distal tip got kinked 1cm from the distal end.It was about to come off.Therefore, the device was replaced with another device with different lot number and the procedure continued.There was no reported patient injury.The device was stored and prepped as per the instructions for use (ifu).The device was not resterilized.There were no anomalies noted when removed from the package.There were no anomalies noted during prep.The lesion was the superficial femoral artery which had chronic total occlusion (cto).A contralateral approach was made with a 6f non-cordis guiding sheath.Other procedural details were requested but are unknown, unavailable, or not applicable.The product was returned for analysis.A non-sterile saber rx 5mm x 30cm 155 was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The balloon was received without being inflated.The unit was thoroughly inspected focusing on the distal tip and a frayed/split/torn condition was observed.No other damages or outstanding details were observed.Sem results showed that the outer surface of the distal tip presented scratch marks near the torn area.This type of damage is commonly caused during the interaction of the unit material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the distal tip outer surface probably led to the torn condition on the distal tip of the unit.It seems the distal tip material was torn either due to the interaction of the unit with calcified spicules located on the lesion or with a sharp object from the outside of the unit.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82204954 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip frayed/split/torn - in-patient¿ was confirmed via device analysis.However, the exact cause cannot be determined.The outer surface of the distal tip presented evidence of scratch marks adjacent to the tear.Vessel characteristics, procedural factors, and handling of the catheter all likely contributed to the reported event as evidenced by device analysis.The distal tip material appears to have been torn either due to the interaction of the tip of the balloon catheter with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.The vessel was described as a chronic total occlusion, these lesions are often highly calcific and tortuous, and caution is recommended when performing interventions.As noted upon device analysis, it appears the distal tip was induced to a tensile force that exceeded the material yield strength after the tear and upon removal from the patient.According to the warnings in 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.¿ according to the safety information of the instructions for use ¿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 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.

• Brand Name: SABER RX5MM30CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11973133
• MDR Text Key: 255990356
• Report Number: 9616099-2021-04625
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

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: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 51005030L
• Device Lot Number: 82204954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/10/2021
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH (6F, DESTINATION TERUMO)