MAUDE Adverse Event Report: CORDIS US. CORP PALMAZ BLUE ON AVIATOR PLUS; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Catalog Number PB1860PPS

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2024

Event Type  malfunction  

Event Description

As reported, the connection piece for the pressure syringe on the 6x18 palmaz blue/aviator was leaking.This meant that the balloon could not be inflated.There was no reported injury to the patient.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82286025 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the connection piece for the pressure syringe on the 6x18 palmaz blue/aviator was leaking.This meant that the balloon could not be inflated.There was no reported injury to the patient.Additional information and device return was requested; however, both were not obtained after multiple attempts made.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, g3, h1, h2, h3 and h6 as reported, the connection piece for the pressure syringe on the 6 x 18 palmaz blue on aviator biliary stent was leaking.This meant that the balloon could not be inflated.There was no reported injury to the patient.Additional information and device return was requested; however, both were not obtained after multiple attempts made.The device was not returned for analysis.A product history record (phr) review of lot 82286025 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿luer hub leakage¿ could not be confirmed as the device was not returned for analysis.The exact cause cannot be determined.It is likely device preparation and/or procedural factors may have contributed to the reported event.However, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the event reported.According to the instructions for use, which is not intended to mitigate risk, ¿caution: always use a cordis sheath introducer (csi) or guiding catheter for the implant procedure to protect the incision site and the transhepatic biliary access tract, and to avoid dislodging the transhepatic biliary stent from the balloon.Preparation of palmaz blue.014 transhepatic biliary stent.Remove the inner package from the box.Open the inner package and carefully extract the packaging tube with the transhepatic biliary stent and the delivery system and the packaging tray containing flushing needle, introducer tube and compliance chart.Hold the packaging tube in one hand.With the other hand, gently grasp the hub and carefully remove the transhepatic biliary stent and the delivery system from the tube.Remove the introducer tube, flushing needle and compliance chart from the tray; discard the tray and packaging tube.Inspect the crimped transhepatic biliary stent for adherence to the balloon.Do not reposition the transhepatic biliary stent or hand crimp.Attach syringe filled with sterile saline to the flushing needle.Remove the protection sheath from the flushing needle, insert the needle into the tip of the catheter and flush the guidewire lumen.Caution: avoid manipulation of transhepatic biliary stent during flushing of guidewire lumen, as this may disrupt the placement of the transhepatic biliary stent on the balloon.Attach a three-way stopcock to the catheter¿s inflation port.Attach a partially filled syringe, open the stopcock and induce negative pressure.Hold the syringe and proximal end of the catheter vertically with the balloon tip pointing down.While maintaining the negative pressure, close the stopcock to the inflation port.Remove the syringe and purge the air.To ensure all air is removed from the balloon and inflation lumen, repeat steps h-k.Prepare inflation device with diluted contrast medium.Connect inflation device to the stopcock that is connected to the catheter inflation port.Open the stopcock to the catheter, the inflation lumen and the balloon will slowly be filled with diluted contrast medium.Caution: do not apply negative or positive pressure to balloon at this time.Note: after prepping, the catheter can be kept in a coiled configuration by looping the catheter and inserting the proximal shaft into the hub clip.Caution: do not clip the distal section of the catheter.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: PALMAZ BLUE ON AVIATOR PLUS
• Type of Device: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 18641415
• MDR Text Key: 334560228
• Report Number: 3007635982-2024-00023
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2024

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
• Device Catalogue Number: PB1860PPS
• Device Lot Number: 82286025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1