MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM ICAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 85417

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

After deploying the stent with no problems, the physician attempted to remove the stent balloon out of the 7fr sheath.As he withdrew the balloon into the sheath he felt resistance when he got to the point of the valve.When he grabbed the balloon with hemostats and pulled, it broke apart from the shaft.He was able to successfully retrieve the balloon.

Manufacturer Narrative

Engineering analysis: the returned device was removed from its packaging and examined to determine the cause of the complaint.The returned contents were the stent delivery system only.The sheath used in the case was not returned.The balloon had been separated from the catheter shaft just before the proximal balloon thermal weld.The proximal balloon bond was still intact.The diameter of the shaft was measured at the break point of the catheter shaft and was 0.054in.The diameter at this location is usually 0.061in.This indicates that the shaft necked down to a smaller diameter due to the excessive force required to remove the balloon prior to breaking.The balloon showed no signs of holes or damage and was able to maintain pressures exceeding 8atm when pressurized using a compression fitting to seal the shaft.The balloon did have some minor deformity on the proximal balloon cone due to the force of entering the introducer sheath.The catheter shaft under the balloon was damaged.The shaft had become kinked at some point during the procedure.It is unclear as to when the kinks in the shaft occurred, but could prohibit rapid deflation of the balloon after the stent had been deployed.The introducer sheath used in the case was not returned.Engineering summary: a full review of the catheter lot history records for the device in question was performed.The records indicate that this lot of catheters passed atriums final lot qualification testing.This inspection requires that the catheter lot must pass the following: ability of the stent and delivery system to be passed through the labeled introducer sheath.Ability to deploy the stent at nominal pressure (8atm).Ability to withdraw the deflated balloon catheter back through the labeled introducer sheath.Ability of the delivery system to withstand 10 inflate/deflate cycles at the rated burst pressure (12atm) without leaks or failures.Balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12atm).Manifold to shaft tensile testing.Samples when tensile tested must not break or separate below 3.37lbs.Result: all (b)(4) quality inspection samples passed this final inspection without any non-conforming devices.All the balloons passed through the 7fr introducer sheath without issue.Conclusion: based on the successful qc lot qualification test data atrium can find no fault with the catheter or catheter lot in question.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 10 continental blvd.; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 4997886
• MDR Text Key: 22818189
• Report Number: 1219977-2015-00231
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2018
• Device Model Number: 85417
• Device Catalogue Number: 85417
• Device Lot Number: 224673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 106