MAUDE Adverse Event Report: CORDIS CASHEL SABER 5MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48005004S

Device Problems Burst Container or Vessel (1074); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/17/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17702787 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, the 5mm 4cm 90 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) burst during the procedure.When the balloon was pulled out, a piece of it was falling inside of the patient.Therefore, the piece of the balloon had to be removed during surgery.The device was used during a pta procedure at the superficial femoral artery (sfa).

Manufacturer Narrative

This device has been received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

During a percutaneous transluminal angioplasty (pta) procedure in the superficial femoral artery (sfa) a 5mm x 4cm x 90 saber rapid exchange (rx) pta balloon catheter (bc) burst at nominal pressure during the first inflation.When the balloon was pulled out (of the patient) a piece of it fell into the femoral artery and was surgically removed by cut down.The event caused a clinically relevant increase in the duration of the procedure because endovascular access was lost.Therefore, the pta procedure was aborted.There was also significant prolongation of the existing hospitalization.The procedure was completed by applying manual compression before conducting surgical cutdown with removal of the ruptured shaft/balloon in the femoral artery.Procedural/product images are not available for review.The 90% occluded lesion was severely calcified with little vessel tortuosity.The device was prepped normally (i.E.Maintain negative pressure) 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.A non-cordis inflation device and contrast media were used with a contrast to saline ratio of 60/40.The same indeflator 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.There was no difficulty advancing the balloon catheter through the vessel or crossing the lesion.The catheter was never in an acute bend.The balloon was inflated once prior to the burst at a nominal atmospheric pressure.There was no unusual force used during the procedure.Other additional procedural details were requested but were unknown.The device was returned for analysis.A non-sterile unit of a saber 5mm x 4cm x 90 was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon appears to have been previously inflated with blood residues inside the balloon and is noted to be separated.No other anomalies were observed.Per sem analysis, the balloon burst was caused by a rupture on the balloon surface.The inner surface presented no anomalies adjacent to the balloon rupture.The outer surface presented evidence of scratch marks adjacent to the balloon 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 17702787 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ and ¿balloon separated - in-patient¿ was confirmed by analysis of the device as a burst was noted to the outer portion of the balloon and it was received separated.The exact causes could not be determined.It is likely vessel characteristics of severe calcification with a 90% occluded vessel contributed to the events reported as it is known that calcium may damage balloon material.Per analysis, the outer surface presented evidence of scratch marks adjacent to the balloon rupture which most probably led to the separation that occurred.Upon attempting to remove the balloon from the vessel, the balloon may have been induced to a tensile force that exceeded the material yield strength.It is likely these procedural factors and handling of the device contributed to the reported events.According to the safety information of the instructions for use ¿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.If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ 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 5MM4CM 90
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9315467
• MDR Text Key: 166638470
• Report Number: 9616099-2019-03349
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032068649
• UDI-Public: 20705032068649
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 48005004S
• Device Catalogue Number: 48005004S
• Device Lot Number: 17702787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 12/16/2019; 01/14/2020
• Supplement Dates FDA Received: 01/10/2020; 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention