MAUDE Adverse Event Report: CORDIS CASHEL SABER RX3MM30CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51003030L

Device Problems Burst Container or Vessel (1074); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 3 mm x 30 cm saber rx percutaneous transluminal angioplasty (pta) balloon catheter (bc) burst at 10 atmospheres (atm).There was no reported patient injury.There was no calcification of lesion and no vessel tortuosity.The device was not used for a chronic total occlusion.The device was stored, handled and prepped per the instructions for use (ifu).The device prepped normally (i.E.Maintain negative pressure).There was no difficulty removing the stylet or any of the sterile packaging components, removing the product from the hoop and removing the protective balloon cover.There were no kinks or other damages noted prior to inserting the product into the patient.The contrast media used was iomeron 350 bracco in 50-50 contrast to saline ratio.The inflation device used (indeflator/syringe) was a non-cordis device and was the same indeflator used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and there was no resistance/friction while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel and crossing the lesion.The catheter was not in an acute bend and 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 event did not cause a clinically relevant increase in the duration of the procedure and did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.The device will be returned for analysis.Other additional procedural details were requested but were unknown.

Manufacturer Narrative

A 3 mm x 30 cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) burst at ten atmospheres (atm).There was no reported patient injury.The device was stored, handled and prepped per the instructions for use (ifu).The device prepped normally (i.E.Maintain negative pressure).There was no difficulty removing the stylet or any of the sterile packaging components, removing the product from the hoop and removing the protective balloon cover.There were no kinks or other damages noted prior to inserting the product into the patient.The contrast media used was iomeron 350 bracco in 50-50 contrast to saline ratio.The inflation device used (indeflator/syringe) was a non-cordis device and was the same indeflator used successfully with other devices.There was no calcification of lesion or vessel tortuosity.The device was not used for a chronic total occlusion.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and there was no resistance/friction while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel and crossing the lesion.The catheter was not in an acute bend and 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).Other additional procedural details were requested but were unknown.The product was returned for analysis.A non-sterile saber rx 3mm 30cm 155cm was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon looked like it had been previously inflated.The unit was thoroughly inspected at naked eye and no anomalies were observed.Per functional analysis, the balloon inflation test was performed.A lab inflator/deflator device was attached to the inflation lumen of unit and pressure applied.Leakage of water was observed on the body shaft transition to balloon area.Per sem analysis, the balloon burst was caused by a rupture on the body shaft transition to the balloon area.The inner surface presented evidence of elongations near to the balloon rupture.The outer surface presented evidence of elongations, puncture holes and scratch marks near to 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 is very likely that the same factors that caused the observed elongations, puncture holes and scratch marks on the body shaft transition to balloon area surface could probably led to the rupture condition found on the received device.It seems 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 82164646 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 during analysis of the returned device.Additionally, a ¿body/shaft - puncture/cut¿ was confirmed during analysis of the returned device.The cause of the balloon burst, and the subsequent body/shaft puncture/cut could not be conclusively determined.However, procedural factors, such as damage to the procedural sheath, may have contributed to the reported event.It is very likely that the same factors that caused the observed elongations, puncture holes and scratch marks on the balloon outer surface could have led to the rupture condition found on the received balloon.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿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/preventive action will be taken at this time.

Manufacturer Narrative

After further review of additional information received the following have been updated accordingly.Per additional information received via manufacturer product evaluation, the outer surface presented evidence of elongations, puncture holes and scratch marks near to the body shaft transition to balloon area rupture.A non-sterile unit of a 3mmx30cm 155 saber rx was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon looks like it¿s been previously inflated.The unit was thoroughly inspected at naked eye and no anomalies were observed.During functional analysis, the balloon inflation 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 on the balloon leakage observed during inflation test, results showed that the balloon burst was caused by a rupture on the body shaft transition to balloon area.The inner surface presented evidence of elongations near to the balloon rupture.The outer surface presented evidence of elongations, puncture holes and scratch marks near to 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 is very likely that the same factors that caused the observed elongations, puncture holes and scratch marks on the body shaft transition to balloon area surface could probably led to the rupture condition found on the received device.It seems 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 review of the manufacturing documentation associated with lot 82164646 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.

• Brand Name: SABER RX3MM30CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9282091
• MDR Text Key: 198963420
• Report Number: 9616099-2019-03335
• 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,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• 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: 51003030L
• Device Catalogue Number: 51003030L
• Device Lot Number: 82164646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1