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

Catalog Number PB1850PPX

Device Problems Leak/Splash (1354); Decrease in Pressure (1490); Material Rupture (1546)

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

Event Date 03/14/2023

Event Type  malfunction  

Event Description

As reported, while using a 5x18 palmaz blue/aviator stent delivery system, the balloon leaked when balloon pressurization was performed.Therefore, the stent could not be effectively released in the delivery system and was subsequently withdrawn from the body.There was no reported patient injury.The stent had reached the lesion along an unknown guidewire.The patient had renal artery stenosis shown on angiography.The device was stored according to the instructions for use (ifu).The device was removed from the package according to the ifu.There were no anomalies noted prior to use.The sds was prepped according to the ifu.There were no difficulties noted during prep.The stent was not manipulated during prep.The stent was properly mounted on the system when inspected prior to use.Prior to inserting the sds in the catheter, the balloon was not inflated or partially inflated.No negative pressure was applied to the sds.The inflation device was in the neutral position when the system was being advanced and withdrawn.There was no resistance or friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter.The lesion was calcified, with moderate tortuosity, and 75% stenosis.The device was not used for a chronic total occlusion.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.There was no difficulty encountered while advancing or tracking the sds towards the lesion.No unusual force was used at any time during the procedure.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The case was completed by replacing the product with a different stent.There was no injury to the patient.The device is being returned for evaluation.

Manufacturer Narrative

A product history review is expected but not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82219913 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: d2, d4, g1, g3, g6, h1, h2, h3 and h6 corrected data- common device name: stents, drains and dilators for the biliary ducts / device product code : fge.While using a 5x18 palmaz blue/aviator stent delivery system (sds), the balloon leaked when balloon pressurization was performed.Therefore, the stent could not be effectively released in the delivery system and was subsequently withdrawn from the body.The lesion was calcified, with moderate tortuosity, and 75% stenosis.There was no reported patient injury.The stent had reached the lesion along an unknown guidewire.The patient had renal artery stenosis shown on angiography.The device was stored according to the instructions for use (ifu).The device was removed from the package according to the ifu.There were no anomalies noted prior to use.The sds was prepped according to the ifu.There were no difficulties noted during prep.The stent was not manipulated during prep.The stent was properly mounted on the system when inspected prior to use.Prior to inserting the sds in the catheter, the balloon was not inflated or partially inflated.No negative pressure was applied to the sds.The inflation device was in the neutral position when the system was being advanced and withdrawn.There was no resistance or friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter.The device was not used for a chronic total occlusion.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.There was no difficulty encountered while advancing or tracking the sds towards the lesion.No unusual force was used at any time during the procedure.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The case was completed by replacing the product with a different stent.There was no injury to the patient.The product was returned for analysis.A non-sterile unit of palmaz blue/aviatorplus 5x18/142p sds was received coiled inside of a clear plastic bag.Per visual analysis the balloon was received not inflated.The stent was not returned for analysis.No other outstanding details were observed.Per functional analysis an inflator/deflator device was attached to the inflation luer hub.Balloon inflation test was done applying positive pressure using the inflator/deflator device; however, the balloon inflation was not successful due to a leakage observed on the balloon.Per sem analysis the balloon surface presented evidence of a rupture condition that may be related to the reported leakage and scratch marks located near this damaged area.This type of damage is 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 surface led to the damaged condition found on the received device.It seems that the material near the damaged area was affected with a sharp object from the outside of the device.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82219913 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage-during positive pressure¿ and ¿balloon burst¿ 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 (calcification with moderate tortuosity and a rate of stenosis of 75%) may have contributed to the event as evidenced by scratch marks noted on the outer surface during analysis.It seems that the material near the damaged area was affected with a sharp object from the outside of the device.According to the safety information in the instructions for use ¿contraindications generally, contraindications to percutaneous transluminal angioplasty (pta) are also contraindications for stent placement.Contraindications include, but may not be limited to: patients with highly calcified lesions resistant to pta.Warnings patients with highly calcified arterial lesions highly resistant to pta may not be suitable for this implant.Precautions prior to use, the product should be examined to verify functionality and integrity.¿ 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

An updated product history review is expected but not yet available.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, while using a 5x18 palmaz blue/aviator stent delivery system, the balloon leaked when balloon pressurization was performed.Therefore, the stent could not be effectively released in the delivery system and was subsequently withdrawn from the body.There was no reported patient injury.The stent had reached the lesion along an unknown guidewire.The patient had renal artery stenosis shown on angiography.The device was stored according to the instructions for use (ifu).The device was removed from the package according to the ifu.There were no anomalies noted prior to use.The sds was prepped according to the ifu.There were no difficulties noted during prep.The stent was not manipulated during prep.The stent was properly mounted on the system when inspected prior to use.Prior to inserting the sds in the catheter, the balloon was not inflated or partially inflated.No negative pressure was applied to the sds.The inflation device was in the neutral position when the system was being advanced and withdrawn.There was no resistance or friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter.The lesion was calcified, with moderate tortuosity, and 75% stenosis.The device was not used for a chronic total occlusion.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.There was no difficulty encountered while advancing or tracking the sds towards the lesion.No unusual force was used at any time during the procedure.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The case was completed by replacing the product with a different stent.There was no injury to the patient.The device is being returned for evaluation.Addendum: product evaluation shows the balloon surface presented evidence of a ruptured condition that may be related to the reported leakage and scratch marks located near this damaged area.

• Brand Name: PALMAZ BLUE ON AVIATOR PLUS
• Type of Device: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; E25 R C92; EI E25 RC92
• 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: 16701720
• MDR Text Key: 312886840
• Report Number: 3007635982-2023-00128
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 20705032062180
• UDI-Public: (01)20705032062180(17)230430(10)82219913
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/21/2023

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
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: PB1850PPX
• Device Lot Number: 82219913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/07/2023
• Supplement Dates Manufacturer Received: 04/13/2023; 06/27/2023; 07/26/2023
• Supplement Dates FDA Received: 05/08/2023; 07/24/2023; 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• 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: UNK GUIDEWIRE
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 67 KG