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

Model Number	KPT1502
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from health care provider via manufacturing representative regarding a patient undergone balloon kyphoplasty for primary osteoporosis.It was reported that when the balloon was inflated by 1 ml, a few drops of contrast agent leaked out from the bifurcated needle portion of the balloon, so the balloon was deflated and replaced with a new one.No leakage of contrast agent into the spinal cord was observed in the images.Level th11.No patient symptoms were reported.No treatment or additional surgery performed as a result of this event.
Additional Manufacturer Narrative
H3: product analysis # (b)(4): part # kpt1502; lot # 228263888 visual and optical inspection did not reveal any damage to the ibt.Functional inspection confirmed the ibt was not able to be press urized/inflated to expose any leaks due to the dried media/contrast in the shaft of the ibt.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 20725161
• Report Number: 9612164-2024-05404
• Device Sequence Number: 17089582
• Product Code: HRX
• UDI-Device Identifier: 00763000031725
• UDI-Public: 00763000031725
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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: 01/04/2026
• Device Model Number: KPT1502
• Device Catalogue Number: KPT1502
• Device Lot Number: 228263888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown