MAUDE Adverse Event Report: CORDIS CORPORATION SABER 3MM30CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48003030X

Device Problem Burst Container or Vessel (1074)

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

Event Type  malfunction  

Event Description

As reported, the balloon of a 3mm x 30cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured during a test outside of the patient.As a result, an unknown balloon catheter was used in place of the 3mm x 30cm 150cm saber pta balloon catheter to complete the procedure.There was no reported injury to the patient as the saber pta balloon catheter was never inserted into the patient.The balloon was not being tested due to an observed malfunction.Information regarding patient age, weight, gender, event date, intended procedure, target lesion, the preparation of the device, type of contrast used, contrast to saline ratio, type of inflation device used, and atmospheres (atm) reached at the point of burst was requested but was not provided.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82226771 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g4, g6, h1, h2, h3, h6, h10.Complaint conclusion: as reported, the balloon of a 3mm x 30cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured during a test outside of the patient.As a result, an unknown balloon catheter was used in place of the 3mm x 30cm 150cm saber pta balloon catheter to complete the procedure.There was no reported injury to the patient as the saber pta balloon catheter was never inserted into the patient.The balloon was not being tested due to an observed malfunction.Information regarding patient age, weight, gender, event date, intended procedure, target lesion, the preparation of the device, type of contrast used, contrast to saline ratio, type of inflation device used, and atmospheres (atm) reached at the point of burst was requested but was not provided.The product was returned for analysis.A non-sterile saber 3mm x 30cm 150 percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis inside a plastic bag.Per visual analysis, no anomalies were observed on the unit at the naked eye.Balloon inflation test was successfully performed.A syringe filled with water was attached to the inflation lumen of the unit and pressure applied.The balloon was inflated as expected.Neither burst nor any anomaly was observed.A product history record (phr) review of lot 82226771 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ was not confirmed through analysis of the returned device.The exact cause of the reported event could not be determined.Per functional analysis, the balloon was inflated with no burst or leaks noted and without any issues to the balloon.It is likely procedural factors and handling of the device contributed to the event reported by the customer.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the event reported by the customer as no anomalies were noted during analysis.It was stated in the event description the ¿balloon catheter ruptured during a test outside of the patient¿, this contraindicates the ifu and is listed as such.According to the instructions for use, ¿preparation: 1.Attach a 3-way stopcock to the inflation port, which is marked ¿balloon¿.2.Attach a partially filled syringe with heparinized saline to the stopcock, open the stopcock to the balloon and induce negative pressure.3.Hold the syringe and proximal end of the catheter above the distal end of the catheter, and hold the balloon vertically with the balloon tip pointing down.4.While maintaining negative pressure close the stopcock to the inflation port.Remove the syringe and purge the air.5.To ensure air contained in the balloon and inflation lumen is removed, apply negative pressure twice as instructed and repeat steps 2-4.6.Without twisting, slide the forming tube off the balloon.7.Prepare an angioplasty inflation system with a 50% solution of contrast medium in sterile saline or similar solution.8.Purge the air from the inflation device.9.Connect the inflation device to the 3-way stopcock that is connected to the catheter inflation port, open the stopcock to the catheter and slowly fill the inflation lumen and the balloon will slowly fill with diluted contrast medium.Caution: do not apply positive or negative pressure to the balloon at this time.Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice.Failure to do so could result in air entering the vascular system.¿ 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 3MM30CM 150
• 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: 13739110
• MDR Text Key: 287194000
• Report Number: 9616099-2022-05449
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069134
• UDI-Public: (01)20705032069134(17)240531(10)82226771
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

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: 05/31/2024
• Device Model Number: 48003030X
• Device Catalogue Number: 48003030X
• Device Lot Number: 82226771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 03/22/2022
• Supplement Dates FDA Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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 BALLOON CATHETER