MAUDE Adverse Event Report: MEDTRONIC MEXICO ARTHROSCOPE

Catalog Number	KE102
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2019
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 a surgery due to acute vertebral compression fracture.Intra-op, it was found that the balloon which was inserted in the vertebral body did not inflate.Distal tip of balloon leaked contrast slowly.Pressure was not very high and appeared on imaging that it would not hold inflation.The procedure was successfully completed with the original product.No patient complication was reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Procedure: kyphoplasty the patient was not allergic to contrast media.
Additional Manufacturer Narrative
Product analysis results: visual inspection did not reveal any damage to the shaft or the balloon of the ibt.The inner guidewire was missing from the ibt.Functional inspection confirmed the ibt was not able to inflate due to dried cement/contrast in the shaft.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARTHROSCOPE
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 9096372
• Report Number: 9612164-2019-03985
• Device Sequence Number: 16799882
• Product Code: HRX
• UDI-Device Identifier: 00763000025632
• UDI-Public: 00763000025632
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 12/23/2019

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: KE102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 09/19/2019; 12/05/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 10/17/2019; 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1