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

Catalog Number K09A

Device Problem Deflation Problem (1149)

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

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

The product was returned with the ibt still inside the cannula.The syringe was connected to the ibt slightly inflated then a (b)(6) pressure was drawn on the balloon.The balloon would not deflate.Several attempts were made to clear anything that may be stuck in the shaft of the ibt, these attempts failed.It was noted that there are several bend lines on the shaft of the balloon where it appears the ibt shaft was bent against the cannula.This has caused the shaft to become deformed and appears to be closing off the shaft when a negative pressure is drawn, creating an area of restriction that is not allowing the balloon to deflate.If information is provided in the future, a supplemental report will be issued.

Event Description

Pre-operative diagnosis for this procedure : primary osteoporosis type of fracture:compression fracture it was reported that intra-op, the balloon could not be deflated.It could be inflated, but could not be deflated easily.The product came in contact with the patient.No patient complications were reported.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7924222
• MDR Text Key: 122305753
• Report Number: 1030489-2018-01317
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00613994703996
• UDI-Public: 00613994703996
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2020
• Device Catalogue Number: K09A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2018
• 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 Age: 76 YR