MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX 4MM25CM 155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51004025L

Device Problem Burst Container or Vessel (1074)

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

Event Date 06/07/2022

Event Type  malfunction  

Event Description

As reported, the balloon of a 4mm x 25cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured during its initial inflation to 8 atmospheres (atm).As a result, another saber pta balloon catheter was used to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a lesion in the superficial femoral artery (sfa) which had a 90% stenosis and was not a chronic total occlusion (cto).The lesion was severely calcified and had mild vessel tortuosity.The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced during insertion of the device.The device was able to track toward the lesion and cross the lesion without difficulty.The device was never put into an acute bend during this procedure.After the rupture occurred, the device was able to be removed easily from the patient and remained in one piece during its removal.Information regarding the patient and the balloon used in place of the 4mm x 25cm 155cm saberx pta was requested but was not provided.The device was discarded and will not be returned.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon of a 4mm x 25cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured during its initial inflation to eight atmospheres (atm).As a result, another saber pta balloon catheter was used to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a lesion in the superficial femoral artery (sfa) which was severely calcified, had mild vessel tortuosity, and 90% stenosis.The lesion was not a chronic total occlusion (cto).The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced during insertion of the device.The device was able to track toward the lesion and cross the lesion without difficulty.The device was never put into an acute bend during this procedure.After the rupture occurred, the device was able to be removed easily from the patient and remained in one piece during its removal.Information regarding the patient and the balloon used in place of the saberx pta was requested but was not provided.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82191570 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of severe calcification with tortuosity and stenosis likely contributed to the reported event as calcification is known to damage balloon material.The balloon material may have encountered calcified spicules during delivery or upon balloon expansion.However, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the event reported.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.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least (b)(4) of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ 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 RX 4MM25CM 155
• 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: 14889318
• MDR Text Key: 299886609
• Report Number: 9616099-2022-05774
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032075937
• UDI-Public: (01)20705032075937(17)230331(10)82191570
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 07/13/2022

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: 03/31/2023
• Device Catalogue Number: 51004025L
• Device Lot Number: 82191570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 07/13/2022
• Date Device Manufactured: 04/24/2020
• 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
• Treatment: UNK SABER PTA BALLOON CATHETER