MAUDE Adverse Event Report: CORDIS CASHEL SABER RX4MM10CM155; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

A 4mm10cm155 saber rx percutaneous transluminal angioplasty (pta) catheter ruptured within nominal pressure after it crossed the lesion on an unspecified guidewire.The balloon catheter was replaced with 4x40 saber rx which was inflated three times and the procedure was continued.There was no patient injury.The device was discarded in the hospital.The target lesion was a chronic total occlusion (cto) in the popliteal artery.

Manufacturer Narrative

A 4mm x 10cm 155cm saber rx percutaneous transluminal angioplasty (pta) catheter ruptured within nominal pressure after it crossed the lesion on an unspecified guidewire.The target lesion was a chronic total occlusion (cto) in the popliteal artery.There was no patient injury.The balloon catheter was replaced with 4x40 saber rx which was inflated three times and the procedure was continued.The product was not returned for analysis.A product history record (phr) review of lot 17661797 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 a chronic total occlusion may have contributed to the reported event.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 limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SABER RX4MM10CM155
• Type of Device: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• MDR Report Key: 8707267
• MDR Text Key: 148301277
• Report Number: 9616099-2019-03024
• 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
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 51004010L
• Device Lot Number: 17661797
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1