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

Catalog Number PB1870BSX

Device Problems Deflation Problem (1149); Inflation Problem (1310); Migration (4003)

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

Event Date 05/19/2023

Event Type  Injury  

Event Description

As reported, when attempting to deploy the stent of a 7mm x 18mm135cm palmaz bule on slalom biliary stent delivery system (sds) in the celiac artery, the balloon would not fully inflate at 10 atmospheres (atm).The physician then inflated the stent balloon to 20 atm and the stent was able to be deployed; however, the balloon could not be deflated.A new inflation device was opened to try and deflate the balloon but was unsuccessful.An attempt to puncture the balloon with a non-cordis.018 guidewire was made but was unsuccessful as well.The inflated balloon was then withdrawn into the patient's aorta; however, there was suspicion that the stent was pulled back during the withdrawal.Multiple attempts to snare the balloon with an unknown snaring device were made but were also unsuccessful.The patient was then transferred to another hospital where the slalom sds was able to be punctured and removed.The patient was stable and discharged post procedure.The device was stored and opened per the instructions for use (ifu) and there was no damage observed upon opening the device.The balloon was prepped with a 50/50 contrast and saline mixture.A 90cm non-cordis catheter sheath introducer (csi) was used for access via the left radial artery.The unknown guidewire was able to cross the lesion and there was no resistance met when delivering the stent.The device will be returned for evaluation.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

A procedural cd was received for analysis, but the report is not yet available.However, it will be submitted within 30 days upon receipt.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.

Manufacturer Narrative

Correction: section d9 was corrected as the device was returned on 07-jun-2023.A review of the manufacturing documentation associated with lot 82264291 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.

Manufacturer Narrative

Complaint conclusion: when attempting to deploy the stent of a 7mm x 18mm135cm palmaz bule on slalom biliary stent delivery system (sds) in the celiac artery, the balloon would not fully inflate at 10 atmospheres (atm).The physician then inflated the stent balloon to 20 atm and the stent was able to be deployed; however, the balloon could not be deflated.A new inflation device was opened to try and deflate the balloon but was unsuccessful.An attempt to puncture the balloon with a non-cordis.018 guidewire was made but was unsuccessful as well.The inflated balloon was then withdrawn into the patient's aorta; however, there was suspicion that the stent was pulled back during the withdrawal.Multiple attempts to snare the balloon with an unknown snaring device were made but were also unsuccessful.The patient was then transferred to another hospital where the slalom sds was able to be punctured and removed.It was reported that the device was intentionally separated in order to remove it from the patient.The patient was stable and discharged post procedure.The device was stored and opened per the instructions for use (ifu) and there was no damage observed upon opening the device.The balloon was prepped with a 50/50 contrast and saline mixture.A 90cm non-cordis catheter sheath introducer (csi) was used for access via the left radial artery.The unknown guidewire was able to cross the lesion and there was no resistance met when delivering the stent.The product was returned for analysis.A non-sterile unit of palmaz blue/slalom x18/135 biliary sds was received coiled inside a clear plastic bag.Per visual analysis the unit was returned inserted inside of an unknown medical device.The unit was removed from the unknown medical device: the balloon was received not inflated with the stent not present.The stent was not returned for analysis.A catheter separated condition in two pieces was observed located approximately 18cm from the distal tip.Due to this separation the core wire is exposed.In the proximal section a second separation was observed located approximately on 120 cm from the distal tip.The separated section of the proximal end including the hub was not returned for analysis.An unknown guidewire is stuck inside the guide wire lumen.No other anomalies were observed.Functional analysis was not performed due to the condition of the product as returned.Per microscopic analysis stent struts marks were observed on the balloon surface.This indicates that the device complied with the stent crimp process.Also, an unknow guidewire is stuck inside the lumen.The edges on the separated area presented evidence of elongations.The elongations found on the plastic material and the plastic deformation are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the material was induced to a tensile force that exceeded the yield strength prior to the separation.Procedural images were provided for review.The images provided support the clinical events as reported, up to the point of stent migration.A product history record (phr) review of lot 82264291 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon inflation difficulty-partial or slow¿ and ¿balloon deflation difficulty-unable to¿ and ¿stent migration¿ were confirmed through analysis of the procedural images provided for review.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 events.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.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.Measure the diameter of the reference duct to determine the appropriate size stent and delivery system.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.Caution: after completely retracting the csi, do not re-advance it over the positioned stent to avoid dislodging the stent.¿ the use of this device in the celiac artery 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.

Manufacturer Narrative

This device has been analyzed but the final, approved draft of the engineering report and its conclusion 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.

• Brand Name: PALMAZ BLUE BILIARY ON SLALOM
• Type of Device: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 17133593
• MDR Text Key: 317208371
• Report Number: 3007635982-2023-00213
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 20705032036198
• UDI-Public: (01)20705032036198(17)251031(10)82264291
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PB1870BSX
• Device Lot Number: 82264291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2022
• 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
• Treatment: TERUMO 90CM SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White