MAUDE Adverse Event Report: CORDIS CORPORATION BLUE/AVIATOR/PLUS 4X15/142P PK; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number PB1540PPX

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149)

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

Event Date 12/30/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82233426 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, a ruptured balloon of a palmaz blue.014 4x15 142cm stent delivery system (sds) was found to be leaked.The leakage was noted on the balloon, and the balloon burst, not the shaft.The balloon took longer than expected to deflate.The stent was not deployed.The system was withdrawn and there was no reported patient injury.The procedure was completed by changing to another unknown stent.The device was used in a renal artery stenosis stent implantation after pressurized release that followed by stent delivery.The contrast to saline ratio was 1:1.The same indeflator was used successfully with other devices.There were no anomalies noted while inflating device with positive pressure.The device was able to be partially inflated to 30 atmospheres (atm).The gauge of the indeflator displayed a loss of pressure when the inflation difficulty was noted.The balloon was able to be deflated normally.The user is trained to the device.The device was prepped and used per instructions for use (ifu) and opened in a sterile field.The device will be returned for evaluation.

Manufacturer Narrative

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

A ruptured balloon of a palmaz blue.014 4x15 142cm stent delivery system (sds) was found to be leaked.The leakage was noted on the balloon, and the balloon burst, not the shaft.The balloon took longer than expected to deflate.The stent was not deployed.The system was withdrawn and there was no reported patient injury.The procedure was completed by changing to another unknown stent.The device was used in a renal artery stenosis stent implantation after pressurized release that followed by stent delivery.The contrast to saline ratio was 1:1.The same indeflator was used successfully with other devices.There were no anomalies noted while inflating device with positive pressure.The device was able to be partially inflated to 30 atmospheres (atm).The gauge of the indeflator displayed a loss of pressure when the inflation difficulty was noted.The balloon was able to be deflated normally.The user is trained to the device.The device was prepped and used per instructions for use (ifu) and opened in a sterile field.The device was returned for analysis.One non-sterile unit of a blue/aviator/plus 4x15/142p pk was received inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.During the visual inspection, the stent was still mounted on the balloon.No anomalies were noted during at naked eye on the components returned for analysis.Functional analysis was performed.First, insertion/withdrawal of an appropriate wire through the guidewire lumen was performed and no difficulties nor impediment was noted.Next an inflator/deflator was connected to the inflation luer hub, and it was attempted to inflate, a leakage was observed on the body/shaft of the unit located approximately at 23.7 cm from distal tip.Due the leakage noted on the body/shaft, sem analysis was performed, and results showed that the leakage on the body/shaft of the blue/aviator/plus 4x15/142p pk device presented evidence of a ruptured/torn condition, along with the damage, scratch marks near the condition were also observed.These 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 probably led to the ruptured/torn condition found on the received device.It seems the material near the damage was ruptured/torn with a sharp object from the outside of the device.A product history record (phr) review of lot 82233426 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon-sds burst - in patient¿ and ¿balloon-sds deflation difficulty - partial or slow¿ were not confirmed via analysis; however, damage to the body shaft was noted.The exact cause could not be determined.Device analysis revealed the body/shaft was torn and a leakage was noted from the torn area upon functional analysis.The outer surface of the shaft presented evidence of scratch marks near the torn area.Based on the information provided it appears the damages were caused by the interaction of the shaft material with a sharp object.It is likely vessel characteristics (although unknown) contributed to the reported event as evidenced by analysis findings.Damages to the body/shaft material may have occurred upon navigation of the sds through the patient¿s vasculature to the lesion.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.When stenting renal arteries, exercise great care to reduce the risk of distal embolization of tissue, atherosclerotic and thrombotic material or cholesterol.Use of a distal embolization protection device could be considered.Do not exceed the rated burst pressure recommended on the label and compliance chart.The rated burst pressure is based on the results of in-vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure-monitoring device is recommended to prevent over pressurization and potential complications.¿ the aviator plus is rated to 14 atmospheres.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: BLUE/AVIATOR/PLUS 4X15/142P PK
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS 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: 16232789
• MDR Text Key: 308357953
• Report Number: 9616099-2023-06234
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 20705032062081
• UDI-Public: (01)20705032062081(17)230930(10)82233426
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: PB1540PPX
• Device Lot Number: 82233426
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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: UNKNOWN INDEFLATOR; UNKNOWN STENT
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 56 KG