MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC XPANDER; SYRINGE, BALLOON INFLATION

Model Number KPT1002

Device Problem Material Rupture (1546)

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

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with an ibt when the balloon was cleaned after being removed and the procedure was proceeded.It was reported that the ibt failed during the first insertion attempt into the vertebral body.On t12- l1, balloon was inflated into vertebral body after bone biopsy.There was bone sclerosis.Rupture occurred during inflation.Rupture occurred during inflation.It is unknown if patient was allergic to the contrast media.The breakage of the balloon did not remain in the patient body.There were no patient symptoms or complications as a result of the event.There was no delay in overall procedure time, in-patient/ prolonged hospitalization, or additional surgery performed.The pre-op diagnosis for this procedure was metastatic bone tumor and the fracture type was a compression fracture.The level implanted was l1.The procedure was completed successfully with the reported product.The patient issue has been resolved and no health damage in the patient was reported.The product will not be replaced by a medtronic product.No further complications were reported/ anticipated.

• Brand Name: XPANDER
• Type of Device: SYRINGE, BALLOON INFLATION
• 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10423812
• MDR Text Key: 205725931
• Report Number: 1030489-2020-01089
• Device Sequence Number: 1
• Product Code: MAV
• 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: Other
• Type of Report: Initial
• Report Date: 08/18/2020

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: KPT1002
• Device Catalogue Number: KPT1002
• Device Lot Number: 219821235
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: No
• 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: 77 YR