MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 7X40 PRECISE PRO RX US CAROTID SYST; STENT, CAROTID

Model Number	PC0740RXC
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned but the engineering report is pending.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a box of the precise pro rapid exchange (rx) carotid self-expanding stent (ses) delivery system was opened but the device was already deployed.There was no reported patient injury.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored and handled according to the ifu.The device was stored in a warehouse in a cath room where humidity and temperature are controlled.There was no damage to any of the packaging.Additional patient and procedural details were requested but were not available.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
A box of the precise pro rapid exchange (rx) carotid self-expanding stent (ses) delivery system was opened but the device was already deployed.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored and handled according to the ifu.The device was stored in a warehouse in a cath room where humidity and temperature are controlled.There was no damage to any of the packaging.Additional patient and procedural details were requested but were not available.There was no reported patient injury.The device was returned for analysis.One non-sterile precise pro rx us carotid syst was received for analysis inside a plastic bag.Per visual analysis, the stent of the unit was received deployed.Nonetheless, the valve of the unit was received tighten/ closed, the hypotube stroke rod was fully retracted and the tip of the unit was observed over cannulated into the outer member.Also, liquid from the valve could be noted when the unit was laid flat on the analysis lab tray for evaluation; liquid probably from the stent unit preparation, indicating a stent system manipulation prior to stent deployment.No defects found on the deployed stent.No other anomalies observed.Per functional analysis, a deployment test was not performed due to the deployed condition of the unit the way it was received for evaluation.Per dimensional analysis, the usable length of the stent delivery system was measured against the precise pro rx packaging assembly specification and it was found within specification.A product history record (phr) review of lot 17901855 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds)-ses-deployment difficulty - premature/prior to use¿ was not confirmed based on the conditions the unit was received for evaluation.Even though the precise pro stent system was received in a complete deployed condition for evaluation; the valve of the unit was received tighten/ closed, the hypotube stroke rod was fully retracted and the tip of the unit was observed over cannulated into the outer member.Also, liquid from the valve could be noted when the unit was laid flat on the analysis lab tray for evaluation; liquid probably from the stent unit preparation, indicating a stent system manipulation prior to the stent deployment.The previous observed conditions on the unit do not correspond to the findings reported in the complaint event description, quote: ¿as reported, a box of the precise pro rapid exchange (rx) carotid self-expanding stent (ses) delivery system was opened but the device was already deployed.¿ analysis results and phr review results do not suggest that the observed conditions are related to the manufacturing process.Procedural and/ or handling factors such as the user¿s interaction with the device during device preparation, may have contributed to the stent premature deployment since the device did not present any obvious indication of a manufacturing defect or anomaly that could contribute to the reported event.The product manufacturing records indicated that the product met specifications before shipment.Also, the packaging tray the unit is packaged in does not allow the stent delivery system to undergo any stent premature deployment condition.The instructions for use (ifu) advises the end user during ¿preparation of stent delivery system- caution: the stent delivery system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.Prep the device in the tray per instructions.Close the tuohy borst valve prior to removing the device from the tray.¿ neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: 7X40 PRECISE PRO RX US CAROTID SYST
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 12287661
• Report Number: 9616099-2021-04764
• Device Sequence Number: 4494902
• Product Code: NIM
• UDI-Device Identifier: 20705032036464
• UDI-Public: (01)20705032036464(17)210930(10)17901855
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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: 09/30/2021
• Device Model Number: PC0740RXC
• Device Catalogue Number: PC0740RXC
• Device Lot Number: 17901855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1