MAUDE Adverse Event Report: STRYKER CORPORATION IVAS - KIT INTERVENTIONAL SPINE IVAS INFLATABLE VERTEBRAL AUGMENTATION SYSTEM; CEMENT, BONE, VERTEBROPLASTY

Model Number 0705315000

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2018

Event Type  malfunction  

Event Description

The patient was having kyphoplasty procedure of their l1 vertebra (1st lumbar) where the provider gets access to the vertebral through pedicle using a needle and hammer.After getting access to the vertebral body removing the inner stylet of the needle, but before injecting the cement, the provider will inflate a balloon inside the vertebral body to create more space for the cement.The balloon is inflated with contrast (isovue 300), and while inflating it during this procedure, the balloon popped.The patients chart did not state any allergy to contrast media.However, the patient told us prior to the procedure that she had a ct scan with iv contrast and had a reaction, although she could not remember exactly what her reaction was.This was discussed pre-procedure will all team members involved (provider, nurse, techs), so everyone was aware.The patient did not have any visible reaction during this procedure after the balloon popped.

• Brand Name: IVAS - KIT INTERVENTIONAL SPINE IVAS INFLATABLE VERTEBRAL AUGMENTATION SYSTEM
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER CORPORATION; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 8083858
• MDR Text Key: 127545447
• Report Number: 8083858
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07613252505969
• UDI-Public: (01)07613252505969
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0705315000
• Device Catalogue Number: 0705315000
• Device Lot Number: 18263012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA