MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. INTRODUCER T34A KYPHON EX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number T34A

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/23/2022

Event Type  malfunction  

Event Description

The patient was scheduled for a thoracic kyphoplasty to be completed with medtronic supplies and the representative on site.During the kyphoplasty the balloon was inflated to open the space prior to injecting cement.When the physician attempted to deflate the balloon to remove it and inject the cement, the balloon was caught on the vertebral body and was torn during the attempt to dislodge.The physician then removed the supplies.Opening a new procedure pack he began the procedure again approaching from the right side of the spine.The second attempt was successful and there were no further complications.The medtronic representative stated he had never seen this happen before.Ultimately it was determined that the fragment of balloon left in the space would not cause any harm to the patient and any further attempts to retrieve it would potentially cause damage.Below is an excerpt from the procedure report in the words of the physician."under real-time fluoroscopic guidance, a 10-gauge cannula was introduced into the left side of the l4 vertebral body using a unipedicular approach.A second 10-gauge introducer needle was introduced into the right l4 pedicle.A balloon catheter was introduced through the left sided cannula and inflated under fluoroscopic guidance.When it came time to withdraw the balloon, the balloon became stuck in the vertebral body, and both the left-sided catheter and introducer needle had to be withdrawn.The catheter broke, leaving a portion of the balloon in the vertebral body." fda safety report id # (b)(4).

• Brand Name: INTRODUCER T34A KYPHON EX
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 15348184
• MDR Text Key: 299307125
• Report Number: MW5111842
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/30/2022

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 Model Number: T34A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female