MAUDE Adverse Event Report: CORDIS CORPORATION LONG GEN / PRO 39 X 80 BIL 135; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG3980BPX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the stent of a palmaz genesis 39 x 80 bil 135 expanded without any assistance; therefore, the stent secured to the vessel wall in an area it was not intended.The physician had to snare the stent out of the patient and the procedure was completed.The device will be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, d4, g3, h1, h2, h3 and h6.The stent of a palmaz genesis 39 x 80 bil 135 expanded without any assistance; therefore, the stent secured to the vessel wall in an area it was not intended.The physician had to snare the stent out of the patient and the procedure was completed.Multiple attempts were made without success to obtain the device and additional information.The product was not returned for analysis.A product history record (phr) review of lot 82172365 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent dislodged - in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics, although unknown, 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.¿ this is therefore considered off label usage.Neither the phr nor the limited information available suggests a design or manufacturing related cause for the reported event; a risk assessment has been opened to further investigate this issue.
Event or Problem Description
As reported, the stent of a palmaz genesis 39 x 80 bil 135 expanded without any assistance; therefore, the stent secured to the vessel wall in an area it was not intended.The physician had to snare the stent out of the patient and the procedure was completed.Multiple attempts were made without success to obtain the device and additional information.

• Brand Name: LONG GEN / PRO 39 X 80 BIL 135
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14408243
• Report Number: 9616099-2022-05630
• Device Sequence Number: 2558317
• Product Code: FGE
• UDI-Device Identifier: 20705032040126
• UDI-Public: (01)20705032040126(17)220531(10)82172365
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/08/2022

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: 05/31/2022
• Device Model Number: PG3980BPX
• Device Catalogue Number: PG3980BPX
• Device Lot Number: 82172365
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 06/08/2022
• Date Device Manufactured: 06/19/2019
• 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: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown