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

Model Number	PB1570BSS
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: a palmaz blue slalom 7x15/80 endovascular balloon-expandable stent (sds) was loose on the balloon, therefore the product was not used.There was no reported patient injury.The product was not returned for analysis.A product history record (phr) review of lot 17756960 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent loose crimp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Handling 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.Open the outer box and reveal the inner package containing the tray with the stent and delivery system and introducer tube.Open the inner package and carefully extract the tray with the stent and delivery system and introducer tube.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.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 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, a palmaz blue slalom 7x15/80 endovascular balloon-expandable stent (sds) was loose on the balloon, the product was not used.There was no reported patient injury.

• 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: 8822490
• Report Number: 9616099-2019-03093
• Device Sequence Number: 19647920
• Product Code: FGE
• UDI-Device Identifier: 20705032035986
• UDI-Public: 20705032035986
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2019

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: 01/31/2021
• Device Model Number: PB1570BSS
• Device Catalogue Number: PB1570BSS
• Device Lot Number: 17756960
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1