MAUDE Adverse Event Report: CORDIS CASHEL SABER 2.5MM20CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48002520X

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 2.5mm x 20cm x 150 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter ruptured on 14 atmosphere (atm) pressure.The device was used in expanding the lower knee lesion.There was no reported patient injury.The device is expected to be returned for evaluation.

Manufacturer Narrative

The 2.5mm x 20cm x 150 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 14 atmospheres (atm).The device was used in expanding a lower knee lesion.There was no reported patient injury.The lesion was severe calcified, there was no vessel tortuosity, there was 90% of stenosis.The device was used for a chronic total occlusion (total occlusion >3 months).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.The device was prepped normally.Non-cordis contrast media was used and a 1:1 contrast to saline ratio was used.A non-cordis inflation device was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter.The catheter was never in an acute bend.The maximum inflation pressure was unknown.The balloon maintained pressure during inflation.The balloon catheter did not kink while being used.The balloon catheter was removed easily.It was removed by pulling out through the catheter.The procedure was completed using another balloon.The product was removed intact (in one piece) from the patient.One product was returned for analysis.A non-sterile saber 2.5mm x 20cm x 150 was returned.Per visual analysis, the balloon appears to have been previously inflated and blood residues were observed inside of it.The unit was thoroughly inspected at naked eye and no other anomalies were observed.Functional analysis was performed, a lab inflator/deflator device was attached to the inflation lumen of unit and pressure applied.A leakage of water was observed on the body/shaft transition to balloon area.Per sem analysis, results revealed that the balloon burst was caused by a rupture on the body/shaft transition to balloon area.The inner surface presented evidence of bulged/peeled off material adjacent to the balloon rupture.The outer surface presented evidence of elongations and scratch marks near the body/shaft transition to balloon area rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It appears the balloon material near the rupture was torn with a sharp object from the outside of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82168345 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¿ was confirmed through analysis of the returned device.A balloon rupture was observed on the balloon¿s body/shaft transition to the balloon area of the catheter.Sem analysis revealed evidence of bulged/peeled off material adjacent to the balloon rupture and elongations and scratch marks near the body/shaft transition to balloon area rupture.These findings indicate the catheter was induced to stretching/pulling events that exceeded the material yield strength and the balloon material adjacent to the rupture was torn with a sharp object from the outside of the balloon.It is very likely that handling of the device, procedural factors and vessel characteristics of severe calcification with stenosis contributed to the events as calcification is known to damage balloon material.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 review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive action will be taken at this time.

Manufacturer Narrative

Addendum for additional information received and section b5 was updated: the lesion was severe calcified, there was no vessel tortuosity, there was (b)(4) of stenosis.The device was used for a chronic total occlusion (total occlusion >3 months).There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device was prepped normally.The contrast media that they used was iodixanol.The contrast to saline ratio was 1:1.The type and brand of inflation device was used is yixinda.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The catheter was never in an acute bend.The maximum inflation pressure was unknown.The balloon maintain pressure during inflation.The balloon catheter did not kink while being used.The balloon catheter was removed easily.It was removed by pulling out through catheter.The procedure was completed using another balloon.The product was removed intact (in one piece) from the patient.The device will be returned for evaluation.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: SABER 2.5MM20CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 9481251
• MDR Text Key: 199107844
• Report Number: 9616099-2019-03406
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069073
• UDI-Public: 20705032069073
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 48002520X
• Device Catalogue Number: 48002520X
• Device Lot Number: 82168345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2020
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1