MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON XPANDER INFLATABLE BONE TAMP

Catalog Number	K09A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis for this procedure: primary osteoporosis type of fracture: compression fracture levels implanted: l1 it was reported that intra-op, the contrast media leaked from the insertion port when pulling out the stylet during balloon inflation.The stylet was then removed, and the operation was continued.Pressure of the balloon prior to leakage was 200psi and volume was 3ml.As there was no leakage of the contrast media into the patient body and the cavity creation was finished as well, the physician started cement injection.No fragment of the balloon remained inside the patient.The operation was completed without any problems; and no patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection did not reveal any pin holes or rupture points in the ibt balloon or ibt shaft.Functional inspection with a sample syringe confirmed the ibt would not inflate due to dried particles of hardened contrast stuck in the tube and the balloon of the ibt.It was unable to determine if the ibt worked properly while in use.Root cause of the event was undetermined.Additional information: if information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Common Device Name: TAMP
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 8664678
• Report Number: 9612164-2019-02134
• Device Sequence Number: 13525880
• Product Code: HXG
• UDI-Device Identifier: 00763000025595
• UDI-Public: 00763000025595
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2019

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: 07/26/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1