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

Catalog Number PB1850PPX

Device Problem Leak/Splash (1354)

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

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis but has not yet been received.

Event Description

As reported, the 5x18 palmaz blue/aviator balloon leaked when balloon was pressurized.Therefore, the stent could not be released and was subsequently withdrawn from the body.The case was completed by replacing to another unknown stent.There was no reported injury to the patient.The angiogram showed that the patient had renal artery stenosis, the stent reached the lesion along the unknown guidewire.The device was stored according to the instructions for use (ifu).The device was removed from the packaging per the ifu.There were no anomalies noted prior to use.The sds was prepped according to ifu guidelines with no difficulty noted.During prep, was the stent was not manipulated.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.Negative pressure was not applied to the sds.The inflation device was in the neutral position when the system was being advanced/withdrawn.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve pr while inserting through the guide catheter.The lesion was noted to be calcified with a 85% stenosis.The vessel had moderate tortuosity.The device was not being used to treat a chronic total occlusion (cto).The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.There was no difficulty encountered while advancing/tracking the sds towards the lesion.Unusual force was not used at any time during the procedure.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, g3, h1, h2, h3 and h6.Additional information is pending and 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.

Event Description

As reported, the 5x18 palmaz blue/aviator balloon leaked when balloon was pressurized.Therefore, the stent could not be released and was subsequently withdrawn from the body.The case was completed by replacing to another unknown stent.There was no reported injury to the patient.The angiogram showed that the patient had renal artery stenosis, the stent reached the lesion along the unknown guidewire.The device was stored according to the instructions for use (ifu).The device was removed from the packaging per the ifu.There were no anomalies noted prior to use.The sds was prepped according to ifu guidelines with no difficulty noted.During prep, was the stent was not manipulated.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.Negative pressure was not applied to the sds.The inflation device was in the neutral position when the system was being advanced/withdrawn.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve pr while inserting through the guide catheter.The lesion was noted to be calcified with a 85% stenosis.The vessel had moderate tortuosity.The device was not being used to treat a chronic total occlusion (cto).The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.There was no difficulty encountered while advancing/tracking the sds towards the lesion.Unusual force was not used at any time during the procedure.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, d3, d4, g3, h1, h2, h3 and h6 a review of the manufacturing documentation associated with lot 82246419 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 5x18 palmaz blue/aviator balloon leaked when balloon was pressurized.Therefore, the stent could not be released and was subsequently withdrawn from the body.The case was completed by replacing to another unknown stent.There was no reported injury to the patient.The angiogram showed that the patient had renal artery stenosis, the stent reached the lesion along the unknown guidewire.The device was stored according to the instructions for use (ifu).The device was removed from the packaging per the ifu.There were no anomalies noted prior to use.The sds was prepped according to ifu guidelines with no difficulty noted.During prep, was the stent was not manipulated.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.Negative pressure was not applied to the sds.The inflation device was in the neutral position when the system was being advanced/withdrawn.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve pr while inserting through the guide catheter.The lesion was noted to be calcified with a 85% stenosis.The vessel had moderate tortuosity.The device was not being used to treat a chronic total occlusion (cto).The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.There was no difficulty encountered while advancing/tracking the sds towards the lesion.Unusual force was not used at any time during the procedure.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The device will be returned for evaluation.

Manufacturer Narrative

The 5x18 palmaz blue/aviator balloon leaked when balloon was pressurized.Therefore, the stent could not be released and was subsequently withdrawn from the body.The case was completed by replacing with another unknown stent.The lesion was noted to be calcified with an 85% stenosis.The vessel had moderate tortuosity.There was no reported injury to the patient.The angiogram showed that the patient had renal artery stenosis, the stent reached the lesion along the unknown guidewire.The device was stored according to the instructions for use (ifu).The device was removed from the packaging per the ifu.There were no anomalies noted prior to use.The sds was prepped according to ifu guidelines with no difficulty noted.During prep, was the stent was not manipulated.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.Negative pressure was not applied to the sds.The inflation device was in the neutral position when the system was being advanced/withdrawn.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and while inserting through the guide catheter.The device was not being used to treat a chronic total occlusion (cto).The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.There was no difficulty encountered while advancing/tracking the sds towards the lesion.Unusual force was not used at any time during the procedure.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The product was returned for analysis.A non-sterile palmaz blue/aviator plus 5x18/142p was received coiled inside of a clear plastic bag.Per visual analysis no damages or anomalies were observed.The balloon was received without being inflated.Per functional analysis an inflator/deflator device attached to the inflation port.Balloon inflation test was done applying positive pressure using the inflator/deflator device with the purpose of reach the rate burst pressure.During this test it was observed that the balloon could not be inflated, therefore an ultrasound washing process was executed by the analyst to attempt clean any dry blood or other type of blockage to be impeding the inflation of the balloon.After the process of inflation was repeat and no results were obtained using the corresponding guide wire the inflation lumen was inspected for any possible obstruction.This analysis result in the location of an obstruction in the interior of the catheter body shaft.An sem/eds analysis confirmed that the matter identified as an obstruction inside the inflation lumen was composed of sodium, chloride, and iodine.The composition of the identified obstruction can be related to saline and contrast solutions that are normally used by the physician during the clinical intervention.A product history record (phr) review of lot 82246419 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¿ was not confirmed through analysis of the returned device.The exact cause of the reported event could not be determined during analysis as it was observed that an obstruction impeded the adequate function of the inflation lumen.Therefore, the reported malfunction could not be properly evaluated.Based on the information available for review, procedural or handling factors may have contributed to the event.According to the precautions in the safety information in the instructions for use ¿prior to use, the product should be examined to verify functionality and integrity.¿ according to the instructions for use, which are not intended as a mitigation of risk, ¿attach a syringe filled with sterile heparinized saline or similar isotonic solution 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 stent during flushing of guidewire lumen, as this may disrupt the placement of the stent on the balloon.Attach a three-way stopcock to the catheter¿s inflation port.Purge the air from a partially filled syringe and connect the syringe to the stopcock.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.To ensure all air is removed from the balloon and inflation lumen, repeat steps.Prepare an inflation device with diluted contrast medium.Purge the air from the inflation device and connect the inflation device to the stopcock that is connected to the catheter inflation port.Caution: non-ionic contrast medium has higher viscosity and precipitation levels than does the ionic type, which may prolong inflation/deflation times.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 the balloon at this time.¿ 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: 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; cashel, co. tipperary; miami lakes, florida 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: 16704893
• MDR Text Key: 312982566
• Report Number: 3007635982-2023-00133
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 20705032062180
• UDI-Public: (01)20705032062180(17)240229(10)82246419
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060877
• 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: 10/18/2023

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: 02/29/2024
• Device Catalogue Number: PB1850PPX
• Device Lot Number: 82246419
• 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: Not provided
• Initial Date FDA Received: 04/07/2023
• Supplement Dates Manufacturer Received: 04/05/2023; 05/18/2023; 10/12/2023
• Supplement Dates FDA Received: 05/01/2023; 06/13/2023; 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2022
• 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: UNK GUIDEWIRE
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 62 KG