MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC BALLOON KYPHOPLASTY ESSENTIALS KIT; ARTHROSCOPE

Catalog Number	NH152PB
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2017
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 unspecified surgery.During surgery, the balloon could not be inflated or filled with contrast agent.Even outside of the patient, the balloon could not be inflated although the scrub tech prepped the balloon and inflation syringe properly before the procedure.The product came in contact with the patient.Patient complications were reported as unknown.

• Brand Name: BALLOON KYPHOPLASTY ESSENTIALS KIT
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7258606
• Report Number: 1030489-2018-00187
• Device Sequence Number: 987324
• Product Code: HRX
• UDI-Device Identifier: 00643169703544
• UDI-Public: 00643169703544
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K041454
• 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
• Report Date (Section B): 02/09/2018

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: 06/13/2019
• Device Catalogue Number: NH152PB
• Device Lot Number: WI491163
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1