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

Model Number	C07060ML
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 10867860
• Report Number: 9616099-2020-04073
• Device Sequence Number: 3766124
• Product Code: NIO
• UDI-Device Identifier: 20705032023839
• UDI-Public: 20705032023839
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020036
• 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
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1