MAUDE Adverse Event Report: CORDIS CORPORATION MAXI LD 7F 16X4 80CM; DILATOR, ESOPHAGEAL

Model Number N/A

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but has not yet been received.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

A 7f 16x4 80cm maxi ld balloon burst inside a patient while inflating at 2 atmospheres (atm).The doctor had to go in and snare part of the balloon that was left behind in patient.The device will be returned for analysis.

Manufacturer Narrative

The target lesion was a 60% occluded lesion in the common iliac vein with no calcification or vessel tortuosity.The access site was the common femoral vein.The brite tip sheath and a storq wire were used in the procedure.There was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover and no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally.The contrast to saline ratio was 1:4.A boston scientific indeflator was used in the procedure and same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel or difficulty crossing the lesion.The catheter was never in an acute bend.The catheter was never in an acute bend.The balloon inflated normally but burst on the first inflation.The maximum inflation pressure was 2 atmospheres (atm).The catheter did not kink while being used.The balloon was not caught in the lesion or in a deployed stent.Resistance was met while withdrawing the device through the sheath or introducer guide.Procedural films are not available.Additional device code is 1528 (difficult to remove).Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

A 7f 16 x 4 x 80cm maxi ld balloon burst inside a patient while inflating at two atmospheres (atm) and resistance was met while withdrawing the device through the sheath or introducer guide.The balloon inflated normally but burst on the first inflation.The doctor had to go in and snare part of the balloon that was left behind in patient.The target lesion was a 60% occluded lesion in the common iliac vein with no calcification or vessel tortuosity.The access site was the common femoral vein.The brite tip sheath and a non-cordis wire were used in the procedure.There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally.The contrast to saline ratio was 1:4.A non-cordis indeflator was used in the procedure and same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel or difficulty crossing the lesion.The catheter was never in an acute bend.The catheter did not kink while being used.The balloon was not caught in the lesion or in a deployed stent.The product was not returned for analysis.A product history record (phr) review of lot 82163173 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp¿ and ¿balloon separated-in-patient¿ and ¿pta/ptca system withdrawal difficulty - through guide/sheath¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of stenosis and procedural handling may have contributed to the events reported.There may have been difficulty removing the device from the stenosed vessel in turn damaging the balloon material, the body/shaft may have been induced to a tensile force that exceeded the material yield strength leading to the separation of device.However, without the return of the device for analysis or procedural films, it is difficult to draw a clinical conclusion between the device and reported events.According to the safety information in 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/preventive action will be taken at this time.

• Brand Name: MAXI LD 7F 16X4 80CM
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8767657
• MDR Text Key: 150279138
• Report Number: 9616099-2019-03058
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K023907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 4171640S
• Device Lot Number: 82161181
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention