MAUDE Adverse Event Report: CORDIS CORPORATION LONG GEN / PRO 29 X 10 BIL 135; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG2910BPX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product history review is expected but has not been completed.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 29 x 10 biliary 135 palmaz genesis balloon expandable stent delivery system (sds) came off of the balloon prior to entering the body.The device was not used in the patient.There was no reported patient injury.The device was properly stored and opened in sterile field.Additional procedural details were requested but are unknown.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h10.Complaint conclusion: a 29 x 10 biliary 135 palmaz genesis balloon expandable stent delivery system (sds) came off the balloon prior to entering the body.The device was not used in the patient.There was no reported patient injury.The device was properly stored and opened in sterile field.Additional procedural details were requested but are unknown.The product was returned for analysis.A non-sterile unit of long genesis / pro 29mm x 10mm biliary 135cm was received coiled inside of a clear plastic bag.Per visual analysis the balloon had not been inflated however the stent was no longer mounted on the balloon.The stent was returned for analysis.No damages or anomalies were observed on the returned unit.Per microscopic analysis stent struts marks were observed on the balloon surface.This indicates that the device complied with the stent crimp process.Also, the returned stent was inspected, and no anomalies or damages were observed.A product history record (phr) review of lot 82228150 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¿ was confirmed through analysis of the returned device.The stent was returned apart from the delivery system.However, the stent struts marks were observed on the balloon surface indicating that the device complied with the stent crimp process.The exact cause of the event could not be determined during analysis.Based on the limited information available for review, procedural/handling factors may have contributed to the event as evidenced by stent struts marks noted on the outer surface of the balloon during analysis indicating appropriate crimping.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.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: LONG GEN / PRO 29 X 10 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: 16117966
• Report Number: 9616099-2023-06208
• Device Sequence Number: 5654734
• Product Code: FGE
• UDI-Device Identifier: 20705032039441
• UDI-Public: (01)20705032039441(17)240630(10)82228150
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/24/2023

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: 06/30/2024
• Device Model Number: PG2910BPX
• Device Catalogue Number: PG2910BPX
• Device Lot Number: 82228150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• 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
• Patient Age: 2 YR
• Patient Sex: Male