MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON EXPRESS II INFLATABLE BONE TAMP

Catalog Number	KE152
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent balloon kyphoplasty at l1 due to vertebral compression fracture.Intra-op, when balloon was inflated, contrast leaked from the top y-intersection of the inflatable bone tamp.The procedure was however completed with the same product.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection did not reveal any damages to the balloon or the shaft of the ibt.Functional inspection with a sample syringe confirmed the ibt when under pressure was leaking out the shaft near the connector valve.It appears the shaft was separated from the valve at one point.Unable to determine root cause of shaft separation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON EXPRESS II 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: 8745451
• Report Number: 9612164-2019-02592
• Device Sequence Number: 2637948
• Product Code: HXG
• UDI-Device Identifier: 00763000025656
• UDI-Public: 00763000025656
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K123771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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: KE152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1