MAUDE Adverse Event Report: CORDIS US. CORP AVANTI; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number	504608X
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	06/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the physician used two different avanti sheaths.The 9f avanti sheath bent and the 8f avanti sheath separated in the patient.The separation was noticed when it was inserted into the patient, it than broke as the inner part was being removed.The sheath separated into two different pieces.The piece was removed from the patient with a snare.Once the piece was removed from the patient, new cordis sheaths were placed, and the procedure was completed per usual.There was no reported injury to the patient.The device was stored in a drawer in the box.There were no anomalies noted when the devices were taken out of the package.The devices were prepped per the ifu with no difficulty reported.The access site was the femoral venous.The intended procedure was an afib ablation via the femoral vein.The lesion did not have anything unusual.Unusual force was not used at any time during the procedure.The sheaths were not torqued against resistance.The devices will be returned for evaluation.
Event or Problem Description
As reported, the physician used two different avanti sheaths.The 9f avanti sheath bent and the 8f avanti sheath separated in the patient.The separation was noticed when it was inserted into the patient, it than broke as the inner part was being removed.The sheath separated into two different pieces.The piece was removed from the patient with a snare.Once the piece was removed from the patient, new cordis sheaths were placed, and the procedure was completed per usual.There was no reported injury to the patient.The device was stored in a drawer in the box.There were no anomalies noted when the devices were taken out of the package.The devices were prepped per the ifu with no difficulty reported.The access site was the femoral venous.The intended procedure was an afib ablation via the femoral vein.The lesion did not have anything unusual.Unusual force was not used at any time during the procedure.The sheaths were not torqued against resistance.The devices will not be returned for evaluation as multiple attempts were made without success.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, g3, h1, h2, h3 and h6.As reported, the physician used two different avanti sheaths.The 9f avanti sheath bent and the 8f avanti sheath separated in the patient.The separation was noticed when it was inserted into the patient, it than broke as the inner part was being removed.The sheath separated into two different pieces.The piece was removed from the patient with a snare.Once the piece was removed from the patient, new cordis sheaths were placed, and the procedure was completed per usual.There was no reported injury to the patient.The device was stored in a drawer in the box.There were no anomalies noted when the devices were taken out of the package.The devices were prepped per the ifu with no difficulty reported.The access site was the femoral vein.The intended procedure was an afib ablation via the femoral vein.The lesion did not have anything unusual.Unusual force was not used at any time during the procedure.The sheaths were not torqued against resistance.The products were not returned for analysis.A product history record (phr) review of lot 18184861 (9f) and 18205038 (8f) revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the devices or images for analysis, the reported customer event involving the 9f sheath ¿catheter sheath introducer (csi)- kinked/bent¿ could not be confirmed.The invent involving the 8f csi ¿catheter sheath introducer (csi)- separated¿ could not be confirmed either.Patient specific anatomical factors and/or manipulating the devices against resistances may have contributed to the reported events.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, ¿if increased resistance is felt upon insertion of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure, and 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 US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17316748
• Report Number: 9616099-2023-06551
• Device Sequence Number: 4036986
• Product Code: DRE
• UDI-Device Identifier: 10705032010153
• UDI-Public: (01)10705032010153(17)260331(10)18205038
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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: 03/31/2026
• Device Catalogue Number: 504608X
• Device Lot Number: 18205038
• Was Device Available for Evaluation?: No
• 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: 07/15/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2023
• 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: SHEATH
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male