MAUDE Adverse Event Report: CORDIS CASHEL SABER 5MM30CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	48005030X
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
As reported, the saber mm30cm 150 balloon was inflated in a very long calcified, stenosed artery, however during inflation, at low atmospheres the balloon exploded, and the doctor couldn't pull out the balloon over the wire.There were no reported patient injuries.After the doctor used a high force for taking the balloon out, it was managed to be removed successfully, however it seems as if part of the balloon remained inside of the patient.Under fluoroscopy the doctor took out the guide wire and the guide catheter and the doctor saw that a part of the balloon with the marker bands was stuck on the guide wire.The user is not sure if more parts are inside of the patient.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There was difficulty removing 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.The device was prepped normally by maintaining negative pressure.A non-cordis contrast media was used, with a contrast to saline ratio 30: 70.A non-cordis indeflator and syringe was used.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 was vessel tortuosity, with more than ninety percent stenosis.The device was used for a chronic total occlusion (cto).There was no difficulty advancing the balloon catheter through the vessel.There was difficulty crossing the lesion.The catheter was never is an acute bend.The plunger depressed into the syringe/indeflator when trying to inflate.The balloon was caught in the lesion.The balloon was not caught in a deployed stent.Removal of the guidewire with the balloon stuck on it plus the sheath was performed.The patient is currently stable.The device will be returned for analysis.
Additional Manufacturer Narrative
After further review of additional information received the following sections g4, g7, h2 and h6 have been updated accordingly.A review of the manufacturing documentation associated with lot 82159410 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.
Additional Manufacturer Narrative
After further review of additional information received the following sections g4, g7, h2, h3 and h6 have been updated accordingly.The saber (5mm x 30cm x 150cm) balloon was inflated in a very long calcified, stenosed artery; however, during inflation, at low atmospheres the balloon exploded, and the doctor could not pull out the balloon over the wire.There were no reported patient injuries.After the doctor used high force to remove the balloon, it was managed to be withdrawn successfully.Although, it seems as if part of the balloon remained inside of the patient.Under fluoroscopy the doctor took out the guide wire and guide catheter and saw that a part of the balloon with the marker bands was stuck on the guide wire.The user is not sure if more parts are inside of the patient.The balloon was caught in the lesion and was not caught in a deployed stent.The balloon was stuck to the guidewire and they were removed with the sheath.There were no kinks or other damages noted prior to inserting the product into the patient.The device was used for a chronic total occlusion (cto).There was no difficulty advancing the balloon catheter through the vessel.There was difficulty crossing the lesion.The catheter was never is an acute bend.The device was prepped normally by maintaining negative pressure.A non-cordis contrast media was used, with a contrast to saline ratio 30: 70.A non-cordis indeflator and syringe was used.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.The plunger depressed into the syringe/indeflator when trying to inflate.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There was difficulty removing the stylet or any of the sterile packaging components.The patient is currently stable.One product was returned for analysis.A non-sterile saber 5mm x 30cm x 150cm balloon catheter was returned.Per visual inspection, the balloon was received coiled inside a plastic bag with an unknown guidewire fully inserted into the saber catheter.The saber balloon revealed a rupture\separation at the balloon proximal section.Also, a separation of the inner body was observed at the catheter distal section.No other damages were found.Per sem analysis, the external surface of the balloon presented evidence of abrasions and scratch marks adjacent to the balloon rupture.It is very likely that the same factors that caused the abrasion and scratch marks on the balloon outer surface also contributed to the rupture found on the received balloon.The internal surface did not present any evidence of damages.The inner body separated section presented evidence of abrasions, as well as elongations at the surrounding areas of the separation.The elongations observed suggest that the device was induced to stretching/pulling events that exceeded the material yield strength prior to the separation.No other issues were noted during the sem analysis.Leak and insertion/withdrawal testing could not be performed due to the condition of the product.A product history record (phr) review of lot 82159410 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen- resistance/friction - in-patient¿ could not be confirmed due to the separation of the balloon and on the inner body.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/separated, and the inner body separated could not be determined.However, sem analysis revealed evidence that the external surface of the balloon had abrasions and scratch marks adjacent to the rupture.It is very likely that these same factors caused the balloon to rupture; furthermore, these results would imply that vessel characteristics may have contributed to the event.The vessel was highly calcified with more than ninety percent stenosis.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/preventive action will be taken at this time.

• Brand Name: SABER 5MM30CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; IS
• MDR Report Key: 8305443
• Report Number: 9616099-2019-02686
• Device Sequence Number: 1619619
• Product Code: LIT
• UDI-Device Identifier: 20705032069578
• UDI-Public: 20705032069578
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 48005030X
• Device Lot Number: 82159410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 02/08/2019; 03/06/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/08/2019; 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention