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

Model Number KPT1502

Device Problems Leak/Splash (1354); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via field representative regarding patient with pre-op diagnosis- primary osteoporosis, compression fracture involved in the balloon kyphoplasty procedure.It was reported that intra-operatively, the stylet could not be removed.When they loosened the stylet, the contrast media came out.There was delay in overall procedure time for less than 60 minutes.The procedure was performed successfully by using the reported product.Labeling was followed throughout the procedure.There were no patient symptoms or complications reported as a result of this event.No health damage in the patient was reported.

Manufacturer Narrative

H3: product analysis :part # kpt1502 : lot # 222715277 visual inspection confirmed only ibt and syringes were returned.Unable to determine root cause of stylet issue.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

Manufacturer Narrative

Updated product analysis : part # kpt1502 ; lot # 222715277 visual inspection confirmed the stylet is present in one of the ibt's and missing in the other one.Opticl inspection did not reveal any punctures on the balloon of the ibt.The ibt with the stylet has been used and dried media is present in the balloon and shaft.The stylet was difficult to remove.There is also dried cement on the shaft of the stylet.Once the stylet was removed it damaged the inner tube.It appears the dried media entered the tube channel and dried during use which caused the stylet to become difficult to remove.Unable to determine root cause of dried media on the stylet shaft.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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¿ INFLATABLE BONE TAMP
• Type of Device: 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12834415
• MDR Text Key: 280930739
• Report Number: 9612164-2021-04467
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00763000031725
• UDI-Public: 00763000031725
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2023
• Device Model Number: KPT1502
• Device Catalogue Number: KPT1502
• Device Lot Number: 222715277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1