MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SMART CONTROL, ILIAC 7X60ML; STENT, ILIAC

Model Number C07060ML

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

A smart control 7 x 60 self-expanding stent delivery system was delivered along the non-cordis guidewire; however, it got stuck in the non-cordis guiding sheath.The doctor pulled its handle and tried to remove it; however, the stent was deployed in the guiding sheath.Therefore, all devices were removed from the patient body and the procedure was interrupted.A brachial approach was made with a 6f non-cordis guiding sheath.A 0.014¿ non-cordis guidewire was delivered into the left iliac artery.Another 0.035¿ non-cordis guidewire was delivered into the right iliac artery.Additional procedural details were requested but are unknown.There was no reported patient injury.The device was not returned for analysis as it was discarded.A product history record (phr) review of lot 17910528 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 device for analysis and based on the information provided, the reported "stent delivery system (sds)-ses~ deployment difficulty - premature/in patient - during withdrawal¿ could not be confirmed and the exact root cause could not be determined.Handling and procedural factors such as vessel characteristics (although unknown) and the user¿s interaction during withdrawal of the device may have led to the reported events.According to the instructions for use ¿if resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to the stent or lumen.If resistance occurs during movement through the sheath, carefully withdraw the stent system.If resistance is felt when initially retracting the outer sheath, do not force deployment.Carefully withdraw the stent system without deploying the stent¿.Neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Event Description

As reported, a 7 x 60 smart control self-expanding stent delivery system was delivered along the non-cordis guidewire; however, it got stuck in the non-cordis guiding sheath.The doctor pulled its handle and tried to remove it; however, the stent was deployed in the guiding sheath.Therefore, all devices were removed from the patient body and the procedure was interrupted.There was no reported patient injury.A brachial approach was made with a 6f non-cordis guiding sheath.A 0.014¿ non-cordis guidewire was delivered into the left iliac artery.Another 0.035¿ non-cordis guidewire was delivered into the right iliac artery.The device will not be returned as it was discarded.Additional procedural details were requested but are unknown.

• Brand Name: SMART CONTROL, ILIAC 7X60ML
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• Manufacturer (Section G): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• Manufacturer Contact: karla castro ; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000 ; 7863138372
• MDR Report Key: 10867860
• MDR Text Key: 217307885
• Report Number: 9616099-2020-04073
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032023839
• UDI-Public: 20705032023839
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2020

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 Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: C07060ML
• Device Catalogue Number: C07060ML
• Device Lot Number: 17910528
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/19/2020
• Date Device Manufactured: 11/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1