MAUDE Adverse Event Report: MEDTRONIC MEXICO ARTHROSCOPE

Catalog Number	KE152
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not 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 kyphoplasty at l1 due to vertebral compression fracture.Intra-op,curette was used to create better path for balloon and balloon was used for inflation.During inflation of the balloon, it ruptured.The balloon ruptured while inflating.The pressure prior to rupture was 300 units.The patient was not allergic to the contrast media.No fragment of balloon was left inside of patient.There were no patient complications as a result of this event.

• 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: 9600329
• Report Number: 9612164-2020-00277
• Device Sequence Number: 13944294
• Product Code: HRX
• UDI-Device Identifier: 00763000025656
• UDI-Public: 00763000025656
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2020

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: KE152
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR