MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SABER 4MM15CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number N/A

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

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

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

A non-sterile unit of a saber 4mm15cm 150 was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon was observed separated on the proximal area of the balloon.No other anomalies were observed.A dimensional analysis was performed to verify the correct od at the proximal balloon seal.The measurement was compared against the specification in effect and the result was found within specification.Inflation test was not possible to perform due to the separated condition of the unit, as received.Per sem analysis on the separated balloon observed during visual review, results showed that the balloon separation was caused by a rupture on the balloon surface.The inner surface presented no anomalies near to the balloon rupture.The outer surface presented evidence of scratch marks near 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 is very likely that the same factors that caused the observed scratch marks and tears on the balloon outer surface could probably led to the rupture 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 review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The reported event by the customer as ¿pta/ptca system - tracking difficulty¿ couldn't be properly evaluated due to the nature of the complaint.Nevertheless, the reported event ¿pta/ptca system - tracking difficulty¿ was not confirmed since the dimensional results for the od at proximal balloon seal were found within specification.The reported event by the customer as ¿balloon - inflation difficulty - unable to inflate¿ was not confirmed since the inflation test couldn¿t be performed on the unit due to the balloon being separated, as received.However, sem analysis results showed that the balloon material presented evidence of scratch marks near 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 is very likely that the same factors that caused the observed scratch marks on the balloon outer surface could probably led to the rupture condition found on the received balloon.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.However, the cause of the unit¿s condition as received, could not be conclusively determined.Neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of unit.No corrective or preventive actions will be taken.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

There was difficulty advancing a 4mm x 15cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter through the vessel and difficulty crossing the lesion.It could not be inflated because the balloon was broken.It was replaced with saber (4x100, 5x150) and expanded step by step, and a smart stent was implanted to complete the operation.Analysis of the returned device indicated balloon separation caused by a rupture on the balloon surface.There was no reported patient injury.The patient had a right lower extremity superficial femoral artery long segment 100% chronic total occlusion (cto) with no vessel tortuosity.A left femoral artery puncture was done and a 6f unknown sheath was placed.A v18 guidewire (non-cordis) was used to open the right lower extremity superficial femoral artery occlusion segment.There was no difficulty removing the packaging components and no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally.There was a 1:1 contrast to saline ratio with the indeflator.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and no resistance/friction while inserting the balloon through the guide catheter.The catheter was never in an acute bend.The plunger depressed into the syringe/indeflator when trying to inflate and the user unable to depress the plunger into the syringe/indeflator when trying to inflate.Two balloons were used for treatment needed.Additional patient details were requested such as demographics, medical history and reason for the procedure but they were unknown.The device will be returned for analysis.

Manufacturer Narrative

There was difficulty advancing a 4mm x 15cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter through the vessel and difficulty crossing the lesion.It could not be inflated because the balloon was broken.It was replaced with saber (4x100, 5x150) and expanded step by step, and a smart stent was implanted to complete the operation.There was no reported patient injury.The patient had a right lower extremity superficial femoral artery long segment of 100% chronic total occlusion (cto) with no vessel tortuosity.A left femoral artery puncture was done and a 6f unknown sheath was placed.A v18 guidewire (non-cordis) was used to open the right lower extremity superficial femoral artery occlusion segment.There was no difficulty removing the packaging components and no kinks or other damages noted prior to inserting the product into the patient.The device prepped normally.There was a 1:1 contrast to saline ratio with the indeflator.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.The catheter was never in an acute bend.The plunger depressed into the syringe/indeflator when trying to inflate and the user unable to depress the plunger into the syringe/indeflator when trying to inflate.Two balloons were used for treatment needed.Additional patient details were requested such as demographics, medical history and reason for the procedure, but they were unknown.One product was returned for analysis.A non-sterile saber 4mm15cm 150 was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon was observed separated on the proximal area of the balloon.No other anomalies were observed.A dimensional analysis was performed to verify the correct od at the proximal balloon seal and the result was found within specification.Inflation test was not possible to perform due to the separated condition of the unit, as received.Per sem analysis on the separated balloon observed during visual review, 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 and tears on the balloon outer surface probably led to the rupture 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 82201542 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¿ were confirmed as the balloon was received separated and sem analysis revealed the balloon material presented evidence of scratch marks near the balloon rupture.The reported ¿pta/ptca system - tracking difficulty¿ could not be properly evaluated due to the nature of the complaint.Nevertheless, this failure was not confirmed since dimensional analysis for the od at the proximal balloon seal were found within specification.The reported ¿balloon - inflation difficulty - unable to inflate¿ was not confirmed as inflation testing could not be performed due to the condition of the device, as received.The exact cause of the balloon burst/separation could not be determined.The vessel was noted to have a 100% chronic occlusion.Sem analysis revealed the external surface of the balloon had scratch marks adjacent to the rupture likely due to calcified spicules from the lesion.It is very likely that these same factors caused the balloon to rupture and separate; furthermore, these results would imply that vessel characteristics contributed to the event as it is known that calcification can cause damage to 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.¿ 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 4MM15CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11694829
• MDR Text Key: 248234124
• Report Number: 9616099-2021-04439
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069486
• UDI-Public: 20705032069486
• 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: 05/04/2021

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: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 48004015X
• Device Lot Number: 82201542
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 05/25/2021
• Supplement Dates FDA Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONTRAST: GE HEALTHCAREINDEFLATOR: MERIT MEDIC