MAUDE Adverse Event Report: CORDIS CASHEL 9X40 PALMAZ GENESIS ® TRANSHEPATIC BILIARY STENT ON OPTA PRO .035" DELIVERY SY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
When the staff opened a 9x40 palmaz genesis ® transhepatic biliary stent on opta pro.035" delivery system in the appropriate manner and when they placed it on the sterile field they saw the stent had fallen off the balloon.So they could not use that device since the stent fell off so they opened another.The procedure was successfully completed with the replacement device.There was no reported patient injury.An iliac case was being performed.There was no damage to the product packaging.The device was stored in the operating room on a cart.There was no difficulty removing the palmaz genesis device from the packaging and no difficulty during any preparation of the device prior to the reported event.No additional patient information is available.The device will not be returned for analysis.
Additional Manufacturer Narrative
Please note update to the udi# in section d4.When the staff opened a 39 x 90 bil 135 palmaz genesis biliary stent on opta pro.035" delivery system in the appropriate manner and when they placed it on the sterile field they saw the stent had fallen off the balloon.So they could not use that device since the stent fell off so they opened another.The procedure was successfully completed with the replacement device.There was no reported patient injury.An iliac case was being performed.There was no damage to the product packaging.The device was stored in the operating room on a cart.There was no difficulty removing the palmaz genesis device from the packaging and no difficulty during any preparation of the device prior to the reported event.No additional patient information is available.The product was not returned for analysis.A product history record (phr) review of lot 82208524 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent dislodged - during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural or handling factors may have contributed to the reported event.According to the safety information in the instructions for use ¿the cordis palmaz genesis transhepatic biliary stent on opta pro.035¿ delivery system is indicated for palliation of malignant neoplasms in the biliary tree.The safety and effectiveness of the palmaz genesis transhepatic biliary stent on opta pro.035¿ delivery system for use in the vascular system have not been established.Prior to stenting, the palmaz genesis transhepatic biliary stent on opta pro.035¿ delivery system should be examined to verify functionality and integrity.Inspect the crimped stent for adherence to the balloon and centered placement in relation to the balloon marker bands.Do not reposition the stent or hand crimp.¿ as this was intended by the operator to be used in the iliac artery it is considered off-label usage.Neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time. device description was updated: a 39 x 90 bil 135 palmaz genesis biliary stent on opta pro .035" delivery system. .

• Brand Name: 9X40 PALMAZ GENESIS ® TRANSHEPATIC BILIARY STENT ON OPTA PRO .035" DELIVERY SY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel E25 R C92; EI E25 RC92
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel E25 R C92; EI E25 RC92
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13723024
• Report Number: 9616099-2022-05433
• Device Sequence Number: 14948767
• Product Code: FGE
• UDI-Device Identifier: 20705032040201
• UDI-Public: (01)20705032040201(17)231130(10)82208524
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K012590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

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: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: PG3990BPX
• Device Lot Number: 82208524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• 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: 9X39 PALMAZ GENESIS
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 86 KG