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

Model Number	PB1570BSS
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 7x15 80 palmaz blue transhepatic biliary balloon expandable stent delivery system was defective and did not expand during delivery.There was no reported patient injury.The product was stored per labeling and opened in a sterile field.The device will be returned for evaluation.
Additional Manufacturer Narrative
The product history review is expected but has not been completed.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10.A review of the manufacturing documentation associated with lot 82183845 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10 a review of the manufacturing documentation associated with lot 82183845 presented no issues during the manufacturing process that can be related to the reported event.This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available due to need for additional testing.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
A 7x15 80 palmaz blue transhepatic biliary balloon expandable stent delivery system (sds) was defective and did not expand during delivery.There was no reported patient injury.The product was stored per labeling and opened in a sterile field.The product was returned for analysis.One non-sterile unit of a blue/slalom 7x15mm/80cm biliary sds was received inside of a clear plastic bag.Per visual analysis the stent was mounted properly, the balloon appeared to not be inflated; however, blood residues were found near the distal marker band.No other anomalies were noted.Per functional analysis a guide wire was successfully passed through the guide wire lumen.An inflator/deflator was then connected to the inflation luer hub, and an inflation was attempted; however it was not possible to inflate even with higher pressure applied.Due to the inability to inflate the balloon, the shaft was cut to insert a wire into the inflation lumen.An impediment was noted, thus the section where the impediment was found was cut; however, no obstruction nor reduction/anomaly of the inflation lumen was noted.Per sem analysis the ruptured balloon of the device presented evidence of scratch marks near the damage.The scratch marks are commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the balloon could probably led to the damaged condition found on the received device.It seems the material near the damage was ruptured with a sharp object (calcium spicules most likely) from the outside of the device since the damages are noted on the external surface.No other anomalies were observed.An ftir analysis was performed to identify the residues found on the balloon and to determine if the residue was inside or outside the component.Results found that the residue were inside the balloon and were biological in nature.A product history record (phr) review of lot 82183845 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ and ¿balloon inflation difficulty unable to inflate¿ were 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, vessel characteristics (although unknown) may have contributed to the event as evidenced by abrasions noted on the outer surface during analysis as the presence of calcification is known to cause damage to balloons.It is not fully understood why the balloon could not be inflated.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.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.¿ as this device is not indicated for endovascular use this 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.
Event or Problem Description
As reported, a 7x15 80 palmaz blue transhepatic biliary balloon expandable stent delivery system was defective and did not expand during delivery.There was no reported patient injury.The product was stored per labeling and opened in a sterile field.The device will be returned for evaluation.

• Brand Name: PALMAZ BLUE BILIARY ON SLALOM
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): CORDIS US CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16112490
• Report Number: 9616099-2023-06204
• Device Sequence Number: 6839060
• Product Code: FGE
• UDI-Device Identifier: 20705032035986
• UDI-Public: 20705032035986
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/25/2023

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: 12/31/2022
• Device Model Number: PB1570BSS
• Device Catalogue Number: PB1570BSS
• Device Lot Number: 82183845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 02/01/2023; 02/01/2023; 04/14/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/22/2023; 03/15/2023; 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2020
• 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
• Patient Sex: Male