MAUDE Adverse Event Report: CORDIS CORPORATION MAXI LD 7F 18X6 110CM; DILATOR, ESOPHAGEAL

Model Number 4161860L

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 11/23/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82202978 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.

Event Description

As reported, a maxi ld 7f 18x6 110cm percutaneous transluminal angioplasty (pta) dilatation catheter was used and inflated normally, but there was a lot of resistance when withdrawing the balloon after deflation.It was impossible to withdraw the balloon normally.After finally withdrawing the balloon, it was found that it did not fold normally during deflation.The balloon was removed by using the guide to pull it out with force.The procedure was then completed with "normal process".There was no patient injury.The device was being used for treatment of a hepatic vein due to budd chiari syndrome.The balloon diameter after deflation was too large and it could not be withdrawn.There was no difficulty removing the product from the hoop, removing the protective balloon cover, or removing the stylet or any of the sterile packaging components.The device was stored and prepped as per the instructions for use (ifu).There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally.A "normal" ratio of contrast and saline was used.The same indeflator was not used successfully with other devices.The balloon was inflated to "balloon working pressure".Other procedural details were requested but are unknown, unavailable, or not applicable.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, a maxi ld 7f 18x6 110cm percutaneous transluminal angioplasty (pta) dilatation catheter was used and inflated normally, but there was a lot of resistance when withdrawing the balloon after deflation.It was impossible to withdraw the balloon normally.After finally withdrawing the balloon, it was found that it did not fold normally during deflation.The balloon was removed by using the guide to pull it out with force.The procedure was then completed with "normal process".There was no patient injury.The device was being used for treatment of a hepatic vein due to budd chiari syndrome.The balloon diameter after deflation was too large and it could not be withdrawn.There was no difficulty removing the product from the hoop, removing the protective balloon cover, removing the stylet, or any of the sterile packaging components.The device was stored and prepped as per the instructions for use (ifu).There were no kinks or other damages noted prior to inserting the product into the patient.The device prepped normally.A "normal" ratio of contrast and saline was used.The same indeflator was not used successfully with other devices.The balloon was inflated to "balloon working pressure".Other procedural details were requested but are unknown, unavailable, or not applicable.One product was returned for analysis.A non-sterile maxi ld 7f 18x6 110cm percutaneous transluminal angioplasty (pta) balloon catheter along with an unknown non-cordis 10.0f catheter sheath introducer was received for analysis inside a clear plastic bag.Per visual analysis, the maxi ld was received fully inserted into the sheath introducer.The maxi ld balloon profile was inspected, and contrast solution was observed inside the balloon of the unit.The unknown sheath introducer was observed severely kinked, and tip prolapsed.The maxi ld outer body was observed kinked and elongated; as well as the inner body ruptured and separated within the clear outer body.No other anomalies were observed.Per functional analysis, the withdrawal of the balloon from the sheath introducer was attempted.However, it could not be achieved due to the damaged condition of both, the maxi ld and the unknown catheter sheath introducer.Next, an inflator/deflator lab sample device filled with water was attached to the inflation lumen of the unit and balloon deflation and inflation test was attempted.Negative and positive pressure was applied to the unit; however, the balloon could neither be deflated nor inflated due to the kinked, elongated and ruptured/separated condition of the unit in which it was received for analysis.Several deflation and inflation attempts were exhausted without success.Per microscopic analysis, the elongated outer body, as well as the ruptured and separated area of the inner body within the outer body were inspected under the vision system.The edges on both separated inner body areas presented a pattern that showed evidence of material elongations.These are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the unit was induced to a tensile force that exceeded the unit inner body material yield strength prior to the separation.A product history record (phr) review of lot 82202978 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon deflation difficulty - partial or slow¿, ¿balloon- withdrawal difficulty¿, and subsequent findings of ¿body/shaft separated¿ were all confirmed during device analysis.However, the exact cause of the reported events cannot be determined.Elongations leading to the separation were noted within the inner body of the device preventing proper deflation of the balloon.These damages are commonly associated with separations caused by material tensile overload and analysis suggests the device was induced to events that exceeded its material yield strength.Therefore, based on the information provided it is likely handling of the devices together and procedural factors contributed to the events reported.According to the instructions for use, ¿note: the rated burst pressure is printed on the package label.In vitro testing has shown that with 95% confidence, 99.9% of the balloons will not burst at or below the rated pressure.Balloons should not be inflated in excess of the rated burst pressure.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Carefully advance the catheter through a sheath or through the percutaneous entry site.Note: gentle counterclockwise rotation of the balloon may ease introduction through the sheath or percutaneous entry site.Note: perform all further catheter manipulations under fluoroscopy.Carefully advance the catheter to the selected site.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.¿ neither the phr nor the limited 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.

Event Description

As reported, a maxi ld 7f 18x6 110cm percutaneous transluminal angioplasty (pta) dilatation catheter was used and inflated normally, but there was a lot of resistance when withdrawing the balloon after deflation.It was impossible to withdraw the balloon normally.After finally withdrawing the balloon, it was found that it did not fold normally during deflation.The balloon was removed by using the guide to pull it out with force.The procedure was then completed with "normal process".There was no patient injury.The device was being used for treatment of a hepatic vein due to budd chiari syndrome.The balloon diameter after deflation was too large and it could not be withdrawn.There was no difficulty removing the product from the hoop, removing the protective balloon cover, or removing the stylet or any of the sterile packaging components.The device was stored and prepped as per the instructions for use (ifu).There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally.A "normal" ratio of contrast and saline was used.The same indeflator was not used successfully with other devices.The balloon was inflated to "balloon working pressure".Other procedural details were requested but are unknown, unavailable, or not applicable.The device will be returned for evaluation.Addendum: product evaluation findings demonstrated the maxi ld inner body was ruptured and separated within the clear outer body.

Manufacturer Narrative

This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available due to need for additional testing.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: MAXI LD 7F 18X6 110CM
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; lakes 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13050989
• MDR Text Key: 285394406
• Report Number: 3009018440-2021-00003
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 20705032002254
• UDI-Public: 20705032002254
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K023907
• 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: 03/10/2022

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 Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 4161860L
• Device Catalogue Number: 4161860L
• Device Lot Number: 82202978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 01/19/2022; 02/23/2022
• Supplement Dates FDA Received: 02/14/2022; 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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: IODIXANOL CONTRAST
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 65 KG