MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK KYPHON XPANDER INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number	K09A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: visual and microscopic evaluation revealed that the ibt was damaged.The balloon had large radial damage to the balloon sheathing, one balloon was cut completely into and was separated from the shaft.This extensive damage is consistent with the balloon being damage from being pulled back through the cannula after a rupture has occurred.Once the material on the balloon has been breached the balloon loses its ability to become pressurized and its ability to hold a negative pressure which aids in the removal process.The balloons were likely cut in the vertebral body then damaged more on the removal process.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively primary osteoporosis and underwent balloon kyphoplasty.During surgery, the con trast medium leaked when the balloon was inflated in the vertebral body at l2.The product was taken out of the body and being checked, it seemed that there was a crack in the balloon.Ibt ruptured during inflation.The patient was not allergic to the contrast media.The product came in contact with the patient.No patient complications were reported as the result of the event.There was a delay of less than 60 minutes.Patient's issue was resolved.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 7936782
• Report Number: 1030489-2018-01327
• Device Sequence Number: 16378901
• Product Code: HRX
• UDI-Device Identifier: 00643169103061
• UDI-Public: 00643169103061
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: K09A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1