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

Catalog Number	K08A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2019
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
Pre-operative diagnosis for this procedure: lumbar spine vertebral fracture type of procedure or technique used: balloon kyphoplasty it was reported that intra-op, while inflating the balloon in the vertebral body, contrast medium leaked from the lower part of balloon.The product came in contact with the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and functional evaluation of the ibt balloon confirmed a leak at the tip of the balloon disallowing inflation.Optical inspection confirmed the inner shaft that holds the wire has broken through the tip of the balloon.The bond appears to have come loose allowing the shaft to shift upward out of the balloon.It is possible the ibt was bent during inflation causing extra pressure causing the bond that keeps the inner wire in the balloon.Root cause of failure is 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: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 8398181
• Report Number: 9612164-2019-00798
• Device Sequence Number: 1990464
• Product Code: HRX
• UDI-Device Identifier: 00763000025588
• UDI-Public: 00763000025588
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K041454
• 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): 05/31/2019

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 Expiration Date: 08/26/2020
• Device Catalogue Number: K08A
• Device Lot Number: 0009312056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Initial Date Received by Manufacturer: 02/10/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1