MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM6CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51005006L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17562055 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, during use a 5mm x 6cm 155 saber rx percutaneous transluminal angioplasty (pta) catheter ruptured.The saber pta was not inflated to rated burst pressure.The procedure was completed with a new non-cordis balloon catheter.There was no patient injury reported.The lesion was the superficial femoral artery with chronic total occlusion and severe calcification.A contralateral approach was made.The device was discarded in the hospital.

Manufacturer Narrative

During use, a 5mm x 6cm x 155 saber rx percutaneous transluminal angioplasty (pta) catheter ruptured.The saber pta was not inflated to rated burst pressure.The procedure was completed with a new non-cordis balloon catheter.There was no patient injury reported.A contralateral approach was made.The lesion was the superficial femoral artery with chronic total occlusion and severe calcification.The product was not returned for analysis.A product history record (phr) review of lot 17562055 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 may have contributed to the reported event as calcification is known to cause damage to 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 RX5MM6CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8939596
• MDR Text Key: 198346481
• Report Number: 9616099-2019-03170
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 51005006L
• Device Catalogue Number: 51005006L
• Device Lot Number: 17562055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER (4MM*4CM ANGIO SCULPT, VOLCANO)