MAUDE Adverse Event Report: MEDTRONIC XOMED INC. BALLOON SEEKER; INSTRUMENT, ENT MANUAL SURGICAL

Model Number 1830707MAX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/23/2014

Event Type  Injury  

Event Description

The surgeon dilated one maxillary sinus and it was fine.As she dilated the other maxillary sinus there was an orbital fracture.Medical intervention was not needed as a result of this fracture.The intended surgery was completed and the patient is okay.She received some minor black-eye and bruising because of the fracture and was told to ¿ice and rest.¿ the sales rep was not in the case, but in communications with the doctor, learned that the patient's anatomy was considered very small.The doctor thinks the balloon size was too big, and that she might not have applied enough lateral pressure.

Manufacturer Narrative

This device is used for therapeutic purposes.Concomitant device: 18infkit ¿ inflator balloon 18infkit, lot # 0208473513, manufacture date: june 23, 2014, expiration date: december 15, 2016, 510(k): k132297.(b)(4).

Manufacturer Narrative

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

• Brand Name: BALLOON SEEKER
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: amy corrales ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328138
• MDR Report Key: 4013687
• MDR Text Key: 21528180
• Report Number: 1045254-2014-00190
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2016
• Device Model Number: 1830707MAX
• Device Catalogue Number: 1830707MAX
• Device Lot Number: 0208515699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 00082 YR