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

Model Number N/A

Device Problems Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problems Myocardial Infarction (1969); Pneumonia (2011)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned but the engineering report is pending.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

When performing a recanalisation of the common iliac artery with a 5x40 mm saber balloon to create a larger lumen for a bigger balloon, the balloon burst during dilatation, and was stuck.When they tried to pull the balloon, it split up and a piece of it was stuck in the artery.It was dragged down to common femoral artery with a guidewire that also was also stuck in a piece of the balloon.The balloon piece was removed with a surgery via the groin with general anesthesia.The patient had a postoperative heart attack and died one week later.The patient remained hospitalized following the surgery and heart attack.An autopsy was not performed.The death certificate listed the official cause of death as heart attack and pneumonia.The device will be returned for analysis.The lesion was calcified and a chronic total occlusion (cto).There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally.The brand of contrast was omnipak 300 at a 50:50 contrast to saline ratio with an everest inflation device by medtronic.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.There difficulty advancing the balloon catheter through the vessel and crossing the lesion.The catheter was never in an acute bend.The balloon inflated normally and the maximum inflation pressure was 5-6 atmospheres.The balloon was not caught in the lesion or in a deployed stent.There was resistance met while withdrawing the device from the vessel, into the guide catheter, into the introducer guide and through the hemostasis valve.The patient had the heart attack a few hours after the procedure which was treated medically.

Manufacturer Narrative

When performing a recanalization of the common iliac artery with a 5mm x 40mm saber balloon to create a larger lumen for a bigger balloon, the balloon burst during dilatation, and was stuck.When they tried to pull the balloon, it split up and a piece of it was stuck in the artery.It was dragged down to common femoral artery with a guidewire that also was also stuck in a piece of the balloon.The balloon piece was removed with surgery via the groin with general anesthesia.The patient had a postoperative heart attack and died one week later.The patient remained hospitalized following the surgery and heart attack.An autopsy was not performed.The death certificate listed the official cause of death as heart attack and pneumonia.The lesion was calcified and a chronic total occlusion (cto).There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally.Non-cordis contrast media was used 50:50 contrast to saline ratio with a non-cordis inflation device.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 difficulty advancing the balloon catheter through the vessel and crossing the lesion.The catheter was never in an acute bend.The balloon inflated normally, and the maximum inflation pressure was five to six atmospheres.The balloon was not caught in the lesion or in a deployed stent.There was resistance met while withdrawing the device from the vessel, into the guide catheter, into the introducer guide and through the hemostasis valve.The patient had the heart attack a few hours after the procedure which was treated medically.The device was returned for analysis.A non-sterile saber 5mm x 4cm x 90 pta balloon catheter was returned.Per visual analysis, the balloon was coiled inside a plastic bag and was received separated.No original packaging was returned.A dimensional analysis was performed to verify the correct od at the proximal balloon seal the result was found within specification.Functional analysis was not possible due to the condition of the device upon arrival.Sem analysis revealed the balloon separation/burst was caused by a rupture on the balloon surface.No anomalies were observed adjacent to the rupture on the inner surface of the balloon.The outer surface presented evidence of bulged/peeled off material and scratch marks adjacent to the balloon rupture.It appears the balloon material adjacent to 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 17683882 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 through analysis of the returned device.The device was received separated and analysis confirmed balloon rupture, although the exact cause of these events cannot be determined.The reported ¿pta/ptca system - withdrawal difficulty¿ was not confirmed since the event cannot be properly evaluated, however dimensional analysis was performed and the results for the od at the proximal balloon seal were found within specifications.Vessel characteristics of calcification and a chronic total occlusion may have contributed to the reported event as calcification is known to cause damage to balloon material.Based on the information provided, there are possible patient, vessel and inherent risk of procedural factors that may have contributed to the events reported related to the post-operative heart attack and ultimate death of the patient.According to the safety information of the instructions for use ¿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.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.Deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Apply negative pressures to the balloon for about 30 - 85 seconds until the balloon is deflated.Remove the vacuum (do not apply pressure) and carefully withdraw and remove the catheter.Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as a unit¿.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 CORPORTION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9179219
• MDR Text Key: 162049611
• Report Number: 9616099-2019-03268
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 48005004S
• Device Lot Number: 17683882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Date Manufacturer Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR