MAUDE Adverse Event Report: CORDIS CASHEL BLUE/SLALOM 6X24/80 BIL PCKGD; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PB2460BSS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a palmaz blue endovascular balloon-expandable stent that was previously implanted was found to be in two pieces after the patient came back with a cta, the second piece had embolized distally.The flow to the bowel was okay at the time.The stent was used for a sma intervention.
Additional Manufacturer Narrative
Complaint conclusion: a palmaz blue endovascular balloon-expandable stent that was previously implanted was found to be in two pieces after the patient came back with a cta (computed tomography angiography), the second piece had embolized distally.The flow to the bowel was okay at the time.The stent was used for a sma (superior mesenteric artery) intervention.The device was not returned for analysis.A product history record (phr) review of lot 17730385 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent fractured-separated - in patient¿ could not be confirmed as the device remains implanted in the patient and therefore was not returned for analysis.The exact cause could not be determined.Vessel characteristics of frequent changes in vessel size and hemodynamics in this particular vessel may have contributed to the reported event.According to the safety information in the instructions for use ¿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.To assure full expansion, inflate to at least the recommended nominal pressure as shown on the label.Therefore this is considered off-label usage.Neither the phr nor the limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: BLUE/SLALOM 6X24/80 BIL PCKGD
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8472082
• Report Number: 9616099-2019-02819
• Device Sequence Number: 1919873
• Product Code: FGE
• UDI-Device Identifier: 20705032036303
• UDI-Public: 20705032036303
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 05/10/2019

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: 09/30/2020
• Device Model Number: PB2460BSS
• Device Catalogue Number: PB2460BSS
• Device Lot Number: 17730385
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1