MAUDE Adverse Event Report: CORDIS US CORP. PALMAZ BLUE BILIARY ON SLALOM; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Catalog Number	PB2470BSX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82234559 presented no issues during the manufacturing process that could be related to the event reported.The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the 7x24mm palmaz blue biliary stent was not seen.After some searching it was found that the balloon mounted stent had fallen off the balloon before it was ever entered into the sheath, so the stent had fallen off as soon as the delivery system was dropped onto the sterile field.The procedure was successfully completed with a new 7x24 stent.There was no reported patient injury.The stent was to be used during an interventional vascular procedure.The stent delivery system was opened onto the table and prepped in the normal fashion.The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use nor difficulty removing the product from the packaging.The catheter had entered the patient and the balloon was inflated normally.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
The 7x24mm palmaz blue biliary stent was not seen.After some searching it was found that the balloon mounted stent had fallen off the balloon before it was ever entered into the sheath, so the stent had fallen off as soon as the delivery system was dropped onto the sterile field.The procedure was successfully completed with a new 7x24 stent.There was no reported patient injury.The stent was to be used during an interventional vascular procedure.The stent delivery system was opened onto the table and prepped in the normal fashion.The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use nor difficulty removing the product from the packaging.The catheter had entered the patient and the balloon was inflated normally.The product was returned for analysis.A non-sterile unit of palmaz blue/slalom 7x24mm 135cm biliary stent delivery system was received coiled inside of a clear plastic bag.Per visual analysis the balloon was received not inflated, and it was observed that the stent was fully removed as received.Additionally, a kinked condition on the stent was observed.Per microscopic analysis stent struts marks were observed on the balloon surface.This indicates that the device complied with the stent crimp process.Additionally, the stent deformation due to the kink condition observed was noted.A product history record (phr) review of lot 82234559 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent dislodged¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural or handling factors may have contributed to the event as evidenced stent crimp marks on the balloon indicating the device complied with the stent crimping process and the kink found on the stent.According to the safety information in the instructions for use ¿prior to stenting, the palmaz blue.018 transhepatic biliary stent system should be examined to verify functionality and integrity.Do not attempt to remove or readjust the stent on the delivery system.The cordis palmaz blue.018¿ transhepatic biliary stent system is indicated for palliation of malignant neoplasms in the biliary tree.Warnings the safety and effectiveness of the palmaz blue.018 transhepatic biliary stent system for use in the vascular system have not been established.Additionally, the intended use of this device in the vascular system is considered off label usage.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: PALMAZ BLUE BILIARY ON SLALOM
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25; el coyol alajuela bld 25, costa rica ; 7863138372
• MDR Report Key: 17793371
• Report Number: 3007635982-2023-00302
• Device Sequence Number: 6454439
• Product Code: FGE
• UDI-Device Identifier: 20705032036358
• UDI-Public: 20705032036358
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 11/15/2023

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: 09/30/2024
• Device Catalogue Number: PB2470BSX
• Device Lot Number: 82234559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: .018 ASAHI GLADIUS WIRE; UNKNOWN CATHETER
• Patient Sex: Male