MAUDE Adverse Event Report: CORDIS CASHEL SABER 4MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48004004S

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented, no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, during a shunt percutaneous transluminal angioplasty, a saber balloon catheter (4mm4cm 90) was delivered to the lesion and inflated to 8 atmospheres (atms), however, the balloon ruptured.There was no patient injury reported.The device was clinically used and has been discarded, so will not be returned for analysis.

Manufacturer Narrative

Complaint conclusion: during a shunt percutaneous transluminal angioplasty, a saber balloon catheter (4mm x 4cm x 90cm) was delivered to the lesion and inflated to eight atmospheres (atms); however, the balloon ruptured.There was no patient injury reported.The device was clinically used.The product was not returned for analysis.A product history record (phr) review of lot 17517808 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.However, the procedure performed was a shunt percutaneous transluminal angioplasty (pta) case.Arteriovenous shunts are often scarred and fibrous in nature and are therefore often resistant to balloon expansion increasing the likelihood of damage to the balloon.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/preventive action will be taken at this time.

• Brand Name: SABER 4MM4CM 90
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8773203
• MDR Text Key: 150578692
• Report Number: 9616099-2019-03062
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069851
• UDI-Public: 20705032069851
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 48004004S
• Device Catalogue Number: 48004004S
• Device Lot Number: 17517808
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1