MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2MM15CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48002015X
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, the 2mm x 15cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter (bc) could not pass over the non-cordis guidewire, so the balloon was not successfully advanced into the patient's blood vessel and directly exited.There was no reported patient injury.It was reported that the device was opened in sterile field.The surgeon performed balloon dilatation for patients with lower extremity artery occlusion.First, the non-cordis guidewire was used to open the blood vessel, and then the saber balloon catheter was used to dilate the diseased blood vessel.The target site was a balloon angioplasty of right anterior tibial artery.The access site was femoral.The device was prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.The lesion was severely calcified.There was no vessel tortuosity.There was occlusive lesion.The device was used for a chronic total occlusion (total occlusion >3 months).The device did not kink nor bend at any time prior to the resistance/friction.The other devices used with the product did not kink nor bend at any time.The product, or any of the other devices used with it, had not been resterilized.The difficulty was not caused by a blockage of possibly injectable material.Another non-cordis balloon was used to complete the operation.The device was returned for analysis.A non-sterile saber 2mm x 15cm 150 was received coiled inside a plastic bag.Per visual analysis, the balloon appears to have been previously inflated.No anomalies were observed on the unit.Functional analysis was performed, the catheter was successfully flushed.Neither obstruction nor resistance was observed during flushing procedure.Then, an 0.018¿ cordis guidewire lab sample was inserted through the guidewire lumen from the hub of the unit and the guidewire couldn¿t be advanced beyond approximately 10 cm from the hub.The unit was inspected, and the guidewire couldn¿t be advanced since the guidewire came out of the lumen from a rupture.The guidewire was then inserted from the distal tip of the unit and couldn¿t also be advance beyond the observed rupture.Sem analysis was performed on the guidewire lumen rupture observed.Dimensional analysis was not performed since the obstruction observed was caused by a rupture on the guidewire lumen.Per microscopic analysis of the torn guidewire lumen, results showed that the outer surface of the lumen presented evidence of elongations near the rupture.No other anomalies were observed.The inner surface of the lumen presented evidence of scratch marks near to the lumen rupture.This type of damage is commonly caused during the interaction of the guidewire lumen material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the guidewire lumen inner surface could probably led to the rupture condition found on the received lumen.It seems the guidewire lumen material near the rupture was torn with a sharp object from the inside of the lumen.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82203694 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen obstructed¿ and subsequent secondary findings of ¿body/shaft frayed/split/torn¿ were confirmed during device analysis.The exact cause of the events could not be determined during analysis.Based on the information available for review, procedural factors and handling of the device may have contributed to this event.It is likely the shaft was damaged as elongations and scratch marks were noted to the unit during analysis indicating the device was subjected to forces beyond its material yield strength weakening the wall of the guidewire lumen.Therefore, when the guidewire was introduced through the lumen it was not able to fully pass.Force may have been used with multiple attempts to insert the guidewire through the lumen likely causing the additional damages noted to the device.The vessel was described as severely calcified with a chronic occlusion.These characteristics likely contributed to the reported events as evidenced by device analysis.According to the instructions for use, which are not intended to mitigate risk, ¿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.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 or Problem Description
As reported, the 2mm x 15cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter (bc) could not pass over the non-cordis guidewire, so the balloon was not successfully advanced into the patient's blood vessel and directly exited.There was no reported patient injury.The device was returned for evaluation.A secondary failure was observed during the evaluation of the unit.The guidewire lumen was observed torn/ruptured.It was reported that the device was opened in sterile field.The surgeon performed balloon dilatation for patients with lower extremity artery occlusion.First, the non-cordis guidewire was used to open the blood vessel, and then the saber balloon catheter was used to dilate the diseased blood vessel.The target site was a balloon angioplasty of right anterior tibial artery.The access site was femoral.The device was prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.The lesion was severely calcified.There was no vessel tortuosity.There was occlusive lesion.The device was used for a chronic total occlusion (total occlusion >3 months).The device did not kink nor bend at any time prior to the resistance/friction.The other devices used with the product did not kink nor bend at any time.The product, or any of the other devices used with it, had not been resterilized.The difficulty was not caused by a blockage of possibly injectable material.Another non-cordis balloon was used to complete the operation.

• Brand Name: SABER 2MM15CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11989852
• Report Number: 9616099-2021-04628
• Device Sequence Number: 16961151
• Product Code: LIT
• UDI-Device Identifier: 20705032069202
• UDI-Public: 20705032069202
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 48002015X
• Device Catalogue Number: 48002015X
• Device Lot Number: 82203694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: V-18 GUIDE WIRE OF BS
• Patient Age: 74 YR
• Patient Weight: 56