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

Catalog Number	K08A
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: visual inspection revealed the ibt was returned with dried media in the balloon.The balloon had expanded and stuck in a snowman like shape.The dried media may have caused the balloon to inflate in a deformed way.Unable to determine root cause of the deformed balloon shape.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
There was a delay of less than 60 minutes as a result of this event.They just needed some minutes in addition to set up a new balloon.
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 presented with osteoporotic fracture; and underwent balloon kyphoplasty at t11 and then at l1.Intra-op, after the successful placement of the inflatable bone tamp (ibt) in the vertebral body (t11), high pressure (300 psi) was needed to inflate the balloon.But only the proximal part of the balloon inflated and no inflation occurred on the distal side of the balloon.After replacing the balloon with a new one, inflation of the balloon was normal on the proximal and distal side.The treatment of the vertebral body (t11) was successfully completed.There was a delay in procedure as a result of this event; but no patient complications were reported.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 9634172
• Report Number: 9612164-2020-00430
• Device Sequence Number: 11616686
• Product Code: HRX
• UDI-Device Identifier: 00763000025588
• UDI-Public: 00763000025588
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K041454
• 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,Followup,Followup
• Report Date (Section B): 03/11/2020

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: K08A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 01/31/2020; 03/05/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/11/2020; 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR