MAUDE Adverse Event Report: CORDIS CORPORATION BLUE/SLALOM 6X18/135 BIL PCKGD; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PB1860BSX
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available.A review of the manufacturing documentation associated with this lot#82197213 presented no issues during the manufacturing process that can be related to the reported complaint.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, when flushing the wire port of the.018" 6mm x 18mm x 135cm palmaz blue on slalom balloon-expandable stent delivery system (sds), the physician saw that the wire port was cracked.The stent was not inserted into the patient.There was no reported patient injury.The device was stored per labelling and opened in sterile field.There was no difficulty removing the product from the hoop, protective balloon cover or when removing the stylet or any of the sterile packaging components.No kinks or other damages were noted prior to using the product.The device was not prep as per facility.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
When flushing the wire port of the.018" 6mm x 18mm x 135cm palmaz blue on slalom balloon-expandable stent delivery system (sds), the physician saw that the wire port was cracked.The stent was not inserted into the patient.There was no reported patient injury.The device was stored per labelling and opened in sterile field.There was no difficulty removing the product from the hoop, protective balloon cover or when removing the stylet or any of the sterile packaging components.No kinks or other damages were noted prior to using the product.The device was not prep as per facility.The product was returned for analysis.A non-sterile unit of a palmaz blue on slalom 6 x18 135cm biliary sds was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon does not appear to have been inflated.However, the guidewire lumen hub was observed cracked.No other anomalies were observed.Per sem analysis the cracked area on the hub revealed evidence of plastic deformation and fatigue striations.Plastic deformation and fatigue striations found on the hub material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the hub material was induced to a tensile force that exceeded the hub material yield strength prior to the separation.No other anomalies were observed during sem analysis.A product history record (phr) review of lot 82197213 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds) - cracked - during prep¿ 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 by plastic deformation and fatigue striations found on the hub material during analysis commonly caused by the application of excessive force.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.Prior to stenting, the palmaz blue.018 transhepatic biliary stent system should be examined to verify functionality and integrity.Hold the tray in one hand.With the other hand, gently grasp the hub and carefully remove the stent/delivery system from the tray.¿ 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: BLUE/SLALOM 6X18/135 BIL PCKGD
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11699562
• Report Number: 9616099-2021-04447
• Device Sequence Number: 3018523
• Product Code: FGE
• UDI-Device Identifier: 20705032036150
• UDI-Public: 20705032036150
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 07/31/2023
• Device Model Number: PB1860BSX
• Device Catalogue Number: PB1860BSX
• Device Lot Number: 82197213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1