MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON XPANDER II INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number	KX153
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that patient with compression fracture underwent balloon kyphoplasty at t11.Intra-op, the balloon was not achieving the height desired and when the contrast was extracted from the balloon, blood was identified in the contrast leading to the conclusion of balloon failure.It was also reported that the balloon was ruptured during deflation.The pressure was less than 400 psi (approx.).The patient was not allergic to contrast media.
Additional Manufacturer Narrative
Product analysis : visual and optical examination of the ibt balloon identified a sharp cut at the proximal lobe of the balloon.The morphology, location and timing of the balloon rupture is consistent with in vivo contact with sharp object, such as bone splinters.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON XPANDER II INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• MDR Report Key: 6325062
• Report Number: 2953769-2017-00013
• Device Sequence Number: 11026895
• Product Code: HRX
• UDI-Device Identifier: 00643169093652
• UDI-Public: 00643169093652
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101864
• 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,Followup
• Report Date (Section B): 03/29/2017

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: KX153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2017
• Supplement Report FDA Received Date: 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1