MAUDE Adverse Event Report: CORDIS MEXICO SABER RX5MM2CM155; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETE

Model Number N/A

Device Problems Decrease in Pressure (1490); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.Please note that the device in the report is not sold in the u.S., but it is similar to other us pta balloon catheters with the lit product code.

Event Description

As reported, the 5mm x 2cm x 155cm saber rapid-exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was delivered to the lesion but it ruptured within its nominal pressure.There was no reported patient injury.The device will not be returned for analysis since it was discarded.

Manufacturer Narrative

The 5mm x 2cm x 155cm saber rapid-exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was delivered to the lesion but it ruptured within its nominal pressure.There was no reported patient injury.The lesion was had severe calcification and moderate vessel tortuosity.There was no difficulty removing the product from the hoop and from the protective balloon cover.There was no difficulty removing the stylet or the sterile packaging components.There were no kinks or other damages noted prior inserting the product into the patient.The device was prep normally and negative pressure was maintained.The same indeflator was used successfully with other devices.There was no resistance or friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty advancing the balloon catheter through the vessel or crossing the lesion.The catheter was not ever in an acute bend and the balloon inflated normally.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 17681306 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 moderate vessel tortuosity may have contributed to the reported event, as calcification is known to damage balloon material.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 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.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 RX5MM2CM155
• Type of Device: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETE
• Manufacturer (Section D): CORDIS MEXICO; juarez 32575 ; MX 32575
• MDR Report Key: 9364891
• MDR Text Key: 198971625
• Report Number: 9616099-2019-03368
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• 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: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 51005002L
• Device Lot Number: 17681306
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1