MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION I-CAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 85424

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

Balloon/catheter broke off during removal of catheter post stent deployment.The broken aspect was successfully removed with no harm to the patient.

Manufacturer Narrative

Additional information: d 10 product returned.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

The details of the complaint provided by the institution indicate that ¿when withdrawing the icast covered stent after stent deployment the balloon separated from the catheter shaft.It is not clear at what point based on the case details when the balloon was separated from the catheter shaft.Additional information received stated the procedure was to treat a fistula in the patients fore arm.An inquiry was sent to the facility requesting information on the amount of time that was allowed for the balloon to deflate and if the balloon had been visualized under fluoroscopy to be fully deflated prior to withdrawal back through the sheath.The requested information was not provided.The device was returned and inspected.Upon opening the returned device it was clear that the balloon had separated from the catheter shaft in the center of the proximal balloon weld.The separation was in the middle of the balloon bond.The shaft appears to have been necked down to a smaller diameter due to the force applied while attempting to pull the balloon back into the 7fr introducer sheath.The balloon was in good condition and did appear to have fluid still in the balloon.To determine if the balloon had a leak in it that may have prevented the balloon from being fully deflated a touhy borst adapter was placed over the proximal balloon weld area and the distal tip of the catheter clamped to prevent fluid from going straight through the guidewire lumen.The balloon was then pressurized to 1atm as the touhy borst was not able to make an adequate seal with such a small portion of the shaft exposed and began to leak.The adapter was removed and an additional clamp placed over the proximal end of the balloon.Firm finger pressure was then applied to the center of the balloon and there were no leaks detected in the balloon.A review of the inflation skives was also conducted.There are two skive holes under the balloon, one in the proximal balloon cone and the other in the distal balloon cone.Both skive holes under the balloon were patent as fluid was pushed through the shaft using the touhy borst adapter and a 20cc syringe.If one or both of the skive holes were not patent during stent deployment, either the stent would have not deployed or the stent would have been pushed off the balloon partially deployed as fluid would only inflate one half of the balloon.Being that the stent was deployed without issue it is reasonable to conclude that the inflation lumens and skive holes were all patent prior to and after stent deployment.Based on the physical review of the product there is nothing that would have prevented the balloon from deflating fully if allowed to deflate for the required 40 seconds as indicated in the product instructions for use (ifu).A review of the relevant data within the device history records was also reviewed.Per the product user requirements the proximal balloon bond must not break at a force below 15 newtons (n).For the proximal balloon bond to break during withdrawal a force greater than 15 n must have been applied while attempting to pull the balloon back through the introducer sheath.A review of the proximal balloon bond tensile force data collected during the quality performance testing that every lot of catheters manufactured is subjected to be reviewed to ensure the minimum specification for proximal bond tensile force was met.The review shows that 20 units were proximal balloon bond tensile tested from this catheter lot and the minimum tensile break force recorded was 26.2 n which is above the specification requirement.A review of the proximal and distal skive dimensions found within the device history records shows that all product dimensional requirements were met for skive dimensions per part specification.The ifu states the following in regards to deflation of the device: deployment of the icast covered stent: "deflate balloon by pulling vacuum on the inflation device to its maximum volume for 40 seconds.Verify full balloon deflation via fluoroscopy before proceeding to step 6." the reason for the separation of the balloon from the catheter shaft could not be confirmed.Based on the review of the physical product, product details provided by the institution and review of the device history records there is no evidence to conclude that the product was non-conforming.There is a possibility that the balloon was not deflated fully prior to attempting to pull the deflated balloon back thorough the introducer sheath.If the balloon is not allowed to fully deflate prior to withdrawal upon withdrawal back through the sheath the remaining fluid in the balloon gets pushed to the distal balloon cone where it forms a bolus of fluid that acts like a plug making withdrawal difficult.If too much force is applied to the catheter the catheter shaft could break.

• Brand Name: I-CAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• MDR Report Key: 11256668
• MDR Text Key: 230502758
• Report Number: 3011175548-2021-00109
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854244
• UDI-Public: 00650862854244
• Combination Product (y/n): N
• PMA/PMN Number: K050814
• 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: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2022
• Device Model Number: 85424
• Device Catalogue Number: 85424
• Device Lot Number: 449381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1