MAUDE Adverse Event Report: CORDIS CASHEL AVANTI; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	504606X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, there was a problem with a 6f avanti + sheath during a post ablation procedure.When removing the sheath, we only have a small part of it.It is believed that 9.5-10 cm is still in the patient.The patient is stable and went to ct.The ablation case was completed, and the patient was brought to surgery.Surgery was able to remove 9-10 cm of the sheath from the patient.It is unknown if the sheath was ablated by the physician.The sheath was stored in the lab in normal temperatures.There were no anomalies noted when the device was taken out of the package.The device was prepped per the ifu and no difficulty was experienced.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18144951 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.This device is available for analysis but has not yet been received.
Event or Problem Description
As reported, there was a problem with a 6f avanti + sheath during a post ablation procedure.When removing the sheath, we only have a small part of it.It is believed that 9.5-10 cm is still in the patient.The patient is stable and went to ct.The ablation case was completed, and the patient was brought to surgery.Surgery was able to remove 9-10 cm of the sheath from the patient.It is unknown if the sheath was ablated by the physician.The sheath was stored in the lab in normal temperatures.There were no anomalies noted when the device was taken out of the package.The device was prepped per the ifu and no difficulty was experienced.The device will be returned for evaluation.One picture related to the reported failure was attached.The picture shows the proximal section of a 6f csi product, the cannula is broken/separated.No other anomalies of the product can be noticed at the attached picture.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, d9, g3, h1, h2, h3 and h6 this device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, there was a problem with a 6f avanti + sheath during a post ablation procedure.When removing the sheath, we only have a small part of it.It is believed that 9.5-10 cm is still in the patient.The patient is stable and went to ct.The ablation case was completed, and the patient was brought to surgery.Surgery was able to remove 9-10 cm of the sheath from the patient.It is unknown if the sheath was ablated by the physician.The sheath was stored in the lab in normal temperatures.There were no anomalies noted when the device was taken out of the package.The device was prepped per the ifu and no difficulty was experienced.The device will be returned for evaluation.One picture related to the reported failure was attached.The picture shows the proximal section of a 6f csi product, the cannula is broken/separated.No other anomalies of the product can be noticed at the attached picture.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis but has not yet been received.
Event or Problem Description
As reported, there was a problem with a 6f avanti + sheath during a post ablation procedure.When removing the sheath, we only have a small part of it.It is believed that 9.5-10 cm is still in the patient.The patient is stable and went to ct.The ablation case was completed, and the patient was brought to surgery.Surgery was able to remove 9-10 cm of the sheath from the patient.It is unknown if the sheath was ablated by the physician.The sheath was stored in the lab in normal temperatures.There were no anomalies noted when the device was taken out of the package.The device was prepped per the ifu and no difficulty was experienced.The device will be returned for evaluation.One picture related to the reported failure was attached.The picture shows the proximal section of a 6f csi product, the cannula is broken/separated.No other anomalies of the product can be noticed at the attached picture.
Additional Manufacturer Narrative
As reported, there was a problem with a 6f avanti + sheath during a post ablation procedure.The sheath separated upon withdrawal with 9.5-10 cm remaining in the patient.The patient was stable and went to ct.The ablation case was completed, and the patient was brought to surgery.Surgery was able to remove 9-10 cm of the sheath from the patient.It is unknown if the sheath was ablated by the physician.The sheath was stored in the lab at normal temperatures.There were no anomalies noted when the device was taken out of the package.The device was prepped per the ifu, and no difficulty was experienced.An image was received for analysis, which revealed a separated cannula.A non-sterile unit of ¿si avanti+ 6f std w/gw no obt¿ was subsequently received for evaluation.During visual inspection a separated cannula was noted.The separated area was inspected with a vision system and evidence of elongations were observed.A product history record (phr) review of lot 18144951 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The failure reported by the customer as ¿catheter sheath introducer (csi)- separated" was confirmed.The returned device was received with a separated cannula.The exact cause of the damaged could not be conclusive determined.The elongations found on the material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the device was induced to a tensile force that exceeded the material yield strength prior to the separation.Procedural/handling factors may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿do not use if package is open or damaged.Remove the sheath when clinically indicated by placing compression on the vessel above the puncture site, and slowly withdraw the csi.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: AVANTI
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 16794446
• Report Number: 9616099-2023-06472
• Device Sequence Number: 7547733
• Product Code: DRE
• UDI-Device Identifier: 10705032010054
• UDI-Public: (01)10705032010054(17)250831(10)18144951
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/03/2023

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 Expiration Date: 08/31/2025
• Device Model Number: 504606X
• Device Catalogue Number: 504606X
• Device Lot Number: 18144951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/24/2023; 06/09/2023; 07/26/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 05/12/2023; 06/30/2023; 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK SHEATH.
• Outcome Attributed to Adverse Event: Life Threatening; Other
• Patient Sex: Unknown