MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO AVANTI + 4F STD W/GW; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	504604X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 4f standard with guidewire avanti plus sheath introducer tore the artery during its introduction.The patient suffered arterial rupture.Suture of the injured artery was done.A new unknown device was used to continue the procedure.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, a 4f standard with guidewire avanti plus sheath introducer tore the artery during its introduction.The patient suffered arterial rupture.Suture of the injured artery was done.A new unknown device was used to continue the procedure.No other information was provided.The device was not returned for analysis.Device history record review of lot: 17955065 was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan and that there were no anomalies during the manufacturing.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint could not be confirmed, and no determination of possible contributing factors could be made.Arterial rupture is a well-known documented potential complication of this type of procedure and is listed in the ifu as such.Vessels that are resistant to angioplasty have a higher risk of intimal dissection during interventional procedures.Factors that may have influenced the event include patient, procedural, pharmacological and lesion.This does not represent device malfunction.Based on the available information there is no evidence to suggest that the event was design or manufacturing related.The dhr reviews does not suggests that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective action will be taken.

• Brand Name: AVANTI + 4F STD W/GW
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11298198
• Report Number: 9616099-2021-04243
• Device Sequence Number: 5036349
• Product Code: DRE
• UDI-Device Identifier: 10705032009935
• UDI-Public: 10705032009935
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K970392
• 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
• Report Date (Section B): 02/22/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 504604X
• Device Catalogue Number: 504604X
• Device Lot Number: 17955065
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention