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

Catalog Number	K08A
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2019
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
Pre-operative diagnosis: primary osteoporosis type of fracture : compression fracture it was reported that intra-op, during inflation, the balloon ruptured and contrast media leaked.Hence, the product was replaced with another one and the procedure was completed.No fragment of the ruptured balloon remained inside the patient.Pressure and volume prior to rupture were 100psi and 1cc respectively.Total delay in overall procedure time as a result of this event was less than 60 minutes.The patient was not allergic to contrast media.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: visual and functional inspection of the ibt balloon revealed a sharp cut/puncture on ibt.Functional inspection with a sample syringe confirmed the balloon would not hold the liquid and leaked out from the puncture.It appears that ibt was cut/punctured at the tip which is consistent with in-vivo contact with sharp object, such as bone splinters.If information is provided in the future, a supplemental report will be issued.

• 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: 8914392
• Report Number: 9612164-2019-03497
• Device Sequence Number: 1746757
• Product Code: HRX
• UDI-Device Identifier: 00763000025588
• UDI-Public: 00763000025588
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/05/2019

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: K08A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1