MAUDE Adverse Event Report: MEDTRONIC MEXICO ARTHROSCOPE

Catalog Number	KX153
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
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 balloon kyphoplasty surgery due to vertebral compression fracture at t12.Intra-op, balloon ruptured during inflation.Balloons were inserted and inflated in a bilateral bkp procedure.Balloons were inflated to 3.5 -4 cc's volume, at 350-400 psi.The balloon on the left side of the patient ruptured at this point.The physician drew back the contrast to the best of his ability, and deflated the balloon on the right.No additional treatment or surgery was performed as a result of this event.No delay in overall procedure as a result of this event.No patient symptoms or complications were reported as result of this event.
Additional Manufacturer Narrative
Additional information: product analysis: visual and optical examination of ibt's revealed a sharp cut at the distal lobe of the balloons.Functional test with a sample syringe confirmed the ibt balloons would not inflate.The morphology, location and timing of the balloon rupture 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: ARTHROSCOPE
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 8801430
• Report Number: 9612164-2019-02923
• Device Sequence Number: 2693971
• Product Code: HRX
• UDI-Device Identifier: 00643169093652
• UDI-Public: 00643169093652
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101864
• 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,Followup
• Report Date (Section B): 12/10/2019

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: KX153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1