MAUDE Adverse Event Report: CORDIS CORPORATION SABER 6MM30CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48006030X

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported, a 6mm x 30cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter was inflated in its nominal pressure from distal superficial femoral artery (sfa) to popliteal artery when it ruptured separating it completely in half.The proximal part of the saber was removed; however, the distal 17cm was not able to be retrieved.Physician tried numerous attempts, strategies, and devices to remove the remaining balloon.The physician then performed stenting (unknown) from common femoral artery (cfa) to popliteal artery, for assurance of restored flow and patency.Moderate calcification was demonstrated at the burst site.The device was stored as per labeling and opened in a sterile field.The device will be returned for evaluation.

Event Description

As reported, a 6mm x 30cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter was inflated in its nominal pressure from distal superficial femoral artery (sfa) to popliteal artery when it ruptured at 10 atms separating it completely in half.The proximal part of the saber was removed; however, the distal 17cm was not able to be retrieved.Physician tried numerous attempts, strategies, and devices to remove the remaining balloon.The physician then performed stenting (unknown) from common femoral artery (cfa) to popliteal artery, for assurance of restored flow and patency.Moderate calcification was demonstrated at the burst site.The device was stored as per labeling and opened in a sterile field.There was no difficulty removing the product from the hoop, protective balloon cover, stylet or any of the sterile packaging components.The device was prepped according to the instructions for use (ifu).The device prepped normally.Visipaque contrast media was used.70% saline and 30% contrast was used.A non cordis inflation device was used and used successfully with other devices.There was moderate calcification throughout the sfa and pop.There was little vessel tortuosity and the vessel was moderately stenosed at 50%.There was no vessel angulation nor was the device used for a chronic total occlusion.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, while inserting the balloon through the guide catheter nor advancing the balloon catheter through the vessel.The balloon was inflated once prior to rupture.The patient is doing well.A procedural film is not available for review.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82224519 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.Alert date and event date were initially reported incorrectly& corrected date is (b)(6) 2021.

Manufacturer Narrative

As reported, a 6mm x 30cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter was inflated to its nominal pressure from the distal superficial femoral artery (sfa) to the popliteal artery when it ruptured at 10 atms separating it completely in half.The proximal part of the saber was removed; however, the distal 17cm was not able to be retrieved.Physician tried numerous attempts, strategies, and devices to remove the remaining balloon.The physician then performed stenting (unknown) from common femoral artery (cfa) to popliteal artery, for assurance of restored flow and patency.Moderate calcification was demonstrated at the burst site.The device was stored as per labeling and opened in a sterile field.There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet, or any of the sterile packaging components.The device was prepped according to the instructions for use (ifu).The device prepped normally.Visipaque contrast media was used.70% saline and 30% contrast was used.A non-cordis inflation device was used and used successfully with other devices.There was moderate calcification throughout the sfa and pop.There was little vessel tortuosity, and the vessel was moderately stenosed at 50%.There was no vessel angulation nor was the device used for a chronic total occlusion.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, while inserting the balloon through the guide catheter nor advancing the balloon catheter through the vessel.The balloon was inflated once prior to rupture.The patient is doing well.A procedural film is not available for review.One product was returned for analysis.A non-sterile 6mm x 30cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter involved in the complaint was received for analysis inside a plastic bag.Per visual analysis, the saber 6mm 30cm 150 was received balloon ruptured- separated at the middle area of the balloon.The distal area separated section of the balloon was not returned for evaluation.No other physical characteristics could be observed at the naked eye.Per microscopic analysis, sem analysis was performed to the received separated balloon unit to identify the possible root cause of the balloon separation with the following results: results showed that the balloon separation was caused by a rupture on the balloon surface.The inner surface presented no anomalies near the balloon rupture.The outer surface presented evidence of scratch marks near 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 is very likely that the same factors that caused the observed scratch marks on the balloon outer surface could have led to the ruptured condition found on the received device.It seems the balloon material near the rupture was torn either due to the interaction of the balloon with calcified spicules located on the lesion or 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 82224519 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¿ and "balloon- separated - in patient¿ were confirmed due to the condition of the product received.The exact cause of the balloon burst/separation could not be determined.Sem analysis revealed the external surface of the balloon had scratch marks adjacent to the rupture.The vessel was noted to have fifty percent stenosis and moderate calcification.It is likely these vessel characteristics and procedural factors may have contributed to the reported events as evidenced by device analysis.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.¿ 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.¿ 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 6MM30CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12380400
• MDR Text Key: 269457493
• Report Number: 9616099-2021-04815
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032068182
• UDI-Public: 20705032068182
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48006030X
• Device Catalogue Number: 48006030X
• Device Lot Number: 82224519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2021
• 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
• Treatment: STENT (UNK).
• Patient Outcome(s): Required Intervention
• Patient Sex: Male