MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM10CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51005010L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

A 5mm x 10mm x 155¿ saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was prepped for a post dilation without any anomalies; however, it ruptured at four atmospheres (atm).There was no reported patient injury.The lesion was the superficial femoral artery.There was severe calcification of lesion, with moderate vessel tortuosity and 90 percent stenosis.The device was stored, handled and prepped per the instructions for use (ifu).There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.Non-cordis contrast media was used during the procedure.The inflation device used was a non-cordis device and was the same indeflator used successfully with other devices.There was no difficulty advancing the balloon catheter through the vessel.The catheter was in an acute bend.There was no unusual force used at any time during the procedure.The product was easily removed intact (in one piece) from the patient.The procedure was completed by using another unknown device.Other additional procedural details were requested but were unknown.The device was not returned for analysis as it was discarded.A product history record (phr) review of lot 17616459 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 tortuosity and 90 percent stenosis likely 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.

Event Description

As reported, a 5 mm x 10 cm 155¿ saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was prepped for a post dilation without any anomalies; however, it ruptured at 4 atmospheres (atm).There was no reported patient injury.The device was stored, handled and prepped per the instructions for use (ifu).The lesion was the superficial femoral artery.There was severe calcification of lesion, moderate vessel tortuosity and 90 percent stenosis.There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop and no difficulty removing the protective balloon cover.There were no kinks or other damages noted prior to inserting the product into the patient.Non-cordis contrast media was used during the procedure.The inflation device used was a non-cordis device and was the same indeflator used successfully with other devices.There was no difficulty advancing the balloon catheter through the vessel.The catheter was in an acute bend.There was no unusual force used at any time during the procedure.The product was easily removed from the patient and was removed intact (in one piece) from the patient.The procedure was completed by using another unknown device.The device will not be returned for analysis because it was discarded.Other additional procedural details were requested but were unknown.

• Brand Name: SABER RX5MM10CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9375277
• MDR Text Key: 198972740
• Report Number: 9616099-2019-03373
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 51005010L
• Device Catalogue Number: 51005010L
• Device Lot Number: 17616459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2019
• Date Device Manufactured: 11/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1