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

Catalog Number	K13A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: visual inspection did not reveal any damage to the balloon.Functional inspection confirmed the tip of the balloon has a pinhole near the proximal peak.This damage is consistent with the balloon coming in contact with bone spurs with the balloon is inflated in the vertebral body.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Other relevant device(s) are: product id: e sbf3214c103ee, serial/lot #: (b)(4), ubd: 21-feb-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis for this procedure: primary osteoporosis it was reported that the patient underwent balloon kyphoplasty at t11 due to compression fracture.Ballon inflation was being performed from the contralateral (left) side.Intra-op, the pressure was hardly raised and the contrast media leaked.The leakage in the contralateral vertebral body was not confirmed.But the pressure became 300 psi when the handle was rotated twice.The surgeon thought this to be strange; therefore, the surgeon inflated the balloon outside the operation field and confirmed that the contrast media leaked from the tip due to the breakage of balloon.Hence, a new product was opened to complete the procedure and a pressure of 150 psi was achieved.Washing was not performed as there was only a small amount of leakage.Although the procedure was delayed by less than 60 minutes due to this event, the procedure was completed successfully without any problems.The surgeon suspected that the reason why the contrast media did not leak to the patient's body from the balloon was that the hole had been blocked by the bone.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 9595777
• Report Number: 9612164-2020-00267
• Device Sequence Number: 2436277
• Product Code: HRX
• UDI-Device Identifier: 00763000025601
• UDI-Public: 00763000025601
• 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): 03/30/2020

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: K13A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 48