MAUDE Adverse Event Report: CORDIS CASHEL BLUE/SLALOM 7X15/80 BIL PCKGD; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PB1570BSS
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The stent of the blue/slalom 7x15/80cm biliary stent delivery system fell off the delivery system while prepping the device.There were no reported patient injuries.The device was stored in the cath lab for approximately one to two months.The product was stored, handled and prepped per the instructions for use (ifu).There was no damage noticed to the device prior to opening the package.There was no difficulty removing the device from the sterile packaging.There was no kink to any part of the device.There was nothing unusual noted to the stent delivery system prior to use.There was no unusual force used at any time.The procedure was completed by using a new 7x15x80 palmaz blue stent.The product was not returned for analysis.A product history record (phr) review of lot 17766576 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.Handling and procedural factors may have contributed to the reported event.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.¿ according to the instructions for use, which is not intended as a mitigation of risk ¿preparation of stent delivery system a.Open the outer box and reveal the inner package containing the tray with the stent and delivery system and introducer tube.B.Open the inner package and carefully extract the tray with the stent and delivery system and introducer tube.C.Hold the tray in one hand.With the other hand, gently grasp the hub and carefully remove the stent/delivery system from the tray.Remove the introducer tube from the tray and discard the tray.D.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.¿ neither the phr nor limited 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.
Event or Problem Description
As reported, the stent of the blue/slalom 7x15/80 bil packaged fell off the delivery system while prepping the device.There were no reported patient injuries.The device was stored in the cath lab for approximately one to two months.The product was stored, handled and prepped per the instructions for use (ifu).There was no damage noticed to the device prior to opening the package.There was no difficulty removing the device from the sterile packaging.There was no kink to any part of the device.There was nothing unusual noted to the stent delivery system prior to use.There was no unusual force used at any time.The procedure was completed by using a new 7x15x80 palmaz blue stent.The device will not be returned for evaluation as it was discarded by the site.

• Brand Name: BLUE/SLALOM 7X15/80 BIL PCKGD
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8564520
• Report Number: 9616099-2019-02882
• Device Sequence Number: 2180991
• Product Code: FGE
• UDI-Device Identifier: 20705032035986
• UDI-Public: 20705032035986
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K040413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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: 02/28/2021
• Device Catalogue Number: PB1570BSS
• Device Lot Number: 17766576
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1