MAUDE Adverse Event Report: CORDIS CORPORATION SLALOM PTA .018 HP 40 4X2; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4394020T

Device Problem Leak/Splash (1354)

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

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

This is one of two reports submitted for the same event.Please reference mfr report #: 9616099-2021-04804.It is unknown if the device will be returned for testing and evaluation.   additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 018¿ 4mm x 2mm 40cm high pressure (hp) slalom thrill percutaneous transluminal angioplasty (pta) balloon catheter and a non-cordis guidewire crossed the lesion.The non-cordis guidewire was removed, and a contrast media was injected from the guidewire lumen to the distal end of the balloon catheter, but air was deflated together with blood.It was stated that air was mixed in from somewhere in the guidewire lumen.Therefore, it was replaced with 018¿ 4mm x 2mm 40cm slalom thrill hp (pta) balloon catheter but the same issue continued.Another non-cordis balloon catheter was used, and the procedure was completed.There was no reported patient injury.This was a shunt percutaneous transluminal angioplasty (pta) case.The lesion was the left forearm.A 4f 5cm unknown sheath was inserted.The lesion was not calcified.There was no vessel tortuosity.The percentage of stenosis was 90%.The devices were not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty removing the products from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the products into the patient.The devices were prepped normally (i.E.Maintain negative pressure).A non-cordis inflation device was used.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloons through the rotating hemostatic valve, or the guide catheter.There was no difficulty advancing the balloon catheters through the vessel.There was no difficulty crossing the lesion.The plungers depressed into the syringe/indeflator when trying to inflate.The balloon catheters did not kink while being used.The balloon catheters were removed easily.The products were removed intact (in one piece) from the patient.The devices will be returned for evaluation.As per the sales rep, the physician had used other slalom thrill pta before and at that time, air did not deflate.

Manufacturer Narrative

This is one of two reports submitted for the same event.Please reference mfr report #: 9616099-2021-04804.Complaint conclusion: as reported, a 018¿ 4mm x 2mm 40cm high pressure (hp) slalom thrill percutaneous transluminal angioplasty (pta) balloon catheter and a non-cordis guidewire crossed the lesion.The non-cordis guidewire was removed, and a contrast media was injected from the guidewire lumen to the distal end of the balloon catheter, but air was deflated together with blood.It was stated that air was mixed in from somewhere in the guidewire lumen.Therefore, it was replaced with 018¿ 4mm x 2mm 40cm slalom thrill hp (pta) balloon catheter but the same issue continued.Another non-cordis balloon catheter was used, and the procedure was completed.There was no reported patient injury.This was a shunt percutaneous transluminal angioplasty (pta) case.The lesion was the left forearm.A 4f 5cm unknown sheath was inserted.The lesion was not calcified.There was no vessel tortuosity.The percentage of stenosis was 90%.The devices were not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty removing the products from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the products into the patient.The devices were prepped normally (i.E.Maintain negative pressure).A non-cordis inflation device was used.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloons through the rotating hemostatic valve, or the guide catheter.There was no difficulty advancing the balloon catheters through the vessel.There was no difficulty crossing the lesion.The plungers depressed into the syringe/indeflator when trying to inflate.The balloon catheters did not kink while being used.The balloon catheters were removed easily.The products were removed intact (in one piece) from the patient.As per the sales rep, the physician had used other slalom thrill pta before and at that time, air did not deflate.The devices were returned for analysis.Two non-sterile slalom pta.018 hp 40 4x2 high pressure (hp) slalom thrill percutaneous transluminal angioplasty (pta) balloon catheters were received for analysis inside a plastic bag.The mentioned non-cordis guide wire involved in the complaint was not returned for evaluation.Per visual analysis of unit number two analyzed under this complaint.The balloon was received deflated, and no anomalies could be observed in the returned device.Per functional analysis, balloon inflation testing was performed; an appropriate.018¿ lab sample guide wire was introduced through the guide wire lumen of the unit and no anomalies found.Then, a lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the unit and positive pressure was applied.The balloon was inflated, and pressure was maintained as expected.Next, negative pressure was applied, and the balloon was completely deflated.No anomalies found.A product history record (phr) review of lot 82183043 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon - leakage - during negative prep¿ was not confirmed during analysis of both devices.Both balloons inflated as expected, neither a leakage nor burst were observed on the balloons surface.Then, negative pressure was applied, and the balloons completely deflated with no leakage or anomalies noted.Both devices performed as intended as functional analysis was performed successfully.Based on the information available for review, it is difficult to draw a clinical conclusion between the device and the reported events.However, procedural factors and handling of the device may have contributed to the reported events.According to the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in-vitro testing.At least 99.9% 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.Use only the recommended balloon inflation medium.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: SLALOM PTA .018 HP 40 4X2
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12352361
• MDR Text Key: 267646880
• Report Number: 9616099-2021-04805
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K003159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• 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: 4394020T
• Device Catalogue Number: 4394020T
• Device Lot Number: 82183043
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE (RADIFOCUS 18); UNKNOWN SHEATH (4F 5CM); GUIDEWIRE (RADIFOCUS 18); UNKNOWN SHEATH (4F 5CM)