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

Catalog 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	12/13/2024
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, when removing of a 6f 11cm avanti plus catheter sheath introducer (csi) during an electrophysiology (ep) his synscopes procedure, the device broke, and part of the device remained inside the patient.The rest of the csi was removed from the patient with a non-cordis lasso.The procedure lasted longer than expected and the patient required occlusive compression and a re-absorbable suture to achieve hemostasis, as well as hospitalization with doppler control.A 22-gauge needle was used during introduction into the patient¿s right femoral vein of the superior right member.The patient was in the decubito-dorsal position during the procedure.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11.This device and received image have been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.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 have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, when removing of a 6f 11cm avanti plus catheter sheath introducer (csi) during an electrophysiology (ep) his syncope procedure, the device broke, and part of the device remained inside the patient.The rest of the csi was removed from the patient with a non-cordis lasso.The procedure lasted longer than expected and the patient required occlusive compression and a re-absorbable suture to achieve hemostasis, as well as hospitalization with doppler control.A 22-gauge needle was used during introduction into the patient¿s right femoral vein of the superior right member.The patient was in the decubito-dorsal position during the procedure.One photo was submitted for analysis.A separated catheter sheath introducer was observed however, it cannot be determined if the introducer is a cordis csi.No other anomalies nor outstanding details could be observed in the image.A non-sterile unit of "si avanti+ 6f std w/gw no obt" was subsequently received for analysis.The returned components included an unknown device, a portion of the body of the cannula, hub, extension tubing, and a stopcock.The csi components were thoroughly inspected for any damage or anomalies that could have contributed to the reported failure, and a separated cannula was noted.The other portion of the cannula was not received for evaluation.No other damage or anomalies were observed on the returned device.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.The visual inspection conducted at high magnification provided evidence of elongation marks near the separation area, which may have contributed to the separation.These elongation marks suggest the material of the body may have been subjected to stress or deformation.The customer¿s complaint reported as "catheter sheath introducer (csi)-separated" was confirmed by the evidence of a separation found on the returned device.While the exact cause of the separation could not be definitively determined during the evaluation, the elongations detected in the material under microscopic examination are typically associated with separations due to material tensile overload.This suggests the device was likely subjected to a tensile force exceeding the material's yield strength before the separation occurred.Procedural or handling factors may have contributed to this failure.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, or an intravascular device through the csi, investigate the cause before continuing.If the cause cannot be determined and corrected, discontinue the procedure and withdraw the csi.¿ based on the available information, 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 FL 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: 21102475
• Report Number: 9616099-2025-00031
• Device Sequence Number: 12955755
• Product Code: DRE
• UDI-Device Identifier: 10705032010054
• UDI-Public: (01)10705032010054(17)270731(10)18352367
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 504606X
• Device Lot Number: 18352367
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2024
• Supplement Date Received by Manufacturer: 01/19/2025; 02/19/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/13/2025; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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: 8F 11CM AVANTI CSI; ABBOT EP CATH 6F; MEDLINE EP TROUSS ELECTROPHY; MEDLINE TROUSSE PETITE; MEDTRONIC LASSO AMPLATZ; MEDTRONIC REVEAL; SMITH & NEPHEW PANS CICAPLAIE 5 X 7; ST. JUDE CATH 6F; TERUMO 10 FR 10CM INTRODUCER; VICRYL J323H 2/0; VYGON EP AIG LL
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic