MAUDE Adverse Event Report: INVIVO CORPORATION 1.5T QUADRATURE LOWER EXTREMITY COIL

Model Number 9896-031-07421

Device Problems Break (1069); Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing for this event.When the investigation is complete a follow-up report will be sent to the fda.

Event Description

The customer reported that the knee/foot coil is damaged.The reporter further stated that the coil heating event created a hole in the plastic.The customer could not perform their mri exam and there was no patient involvement.

Manufacturer Narrative

Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

A ge 472 ge-64 (transmit/receive coil), 12 nc 4535-300-08991 and (b)(6) was delivered to invivo's service & repair department on 20-dec-2019.No patient heating complaints were reported.During inspection it was noted that a hole was present in the housing of the coil at the point where a patient would usually be during a scan.During the repair inspection process, a heating situation was observed.No other information was provided.The coil was sent for repair and forwarded to engineering.Upon receipt in engineering the coil was determined to be in a condition that would not allow further testing.Severe damage has rendered the assembly and the parts used in the coil to be non-functional.A hole was present in the housing, that is clear indication of a high temperature event in the coil.The coil was opened and inspected right underneath the hole.There are no components present on the pcb that are present below the hole.Discoloration was observed on the pcb that indicated that heating was coming from something near the pcb but not from the pcb directly underneath the hole.There are clear signs of overheating on this pcb with severe heat damage to the quad hybrid.Upon inspection it was further noted that heat had melted the epoxy or binding agent within the hybrid and it fused to the board.This was the cause of the extreme heat that caused the hole in the plastic.Upon further inspection, it was noticed that the capacitor c19 fell off the board.This capacitor is used to match the coil to the quad combiner for transferring maximum signal from the receive element to the combiner.A loss of this capacitor will result in very poor power transfer and the quad combiner would not have been damaged the way it is damaged.The capacitor most probably fell off due to the heat generated from the combiner.The coil was severely damaged and further testing could not be performed on the coil.The datasheet of the quad combiner was reviewed.The quad hybrid is capable of handling 800 w of power and the quad hybrid will never experience this level of power during normal use.A power of greater than 800 w can easily be generated by the body coil of the mri system, that can generate a power of greater than 10kw.This fact points to the conclusion that the coil was left in the mri system and the body coil was turned on.The isolation port of the coil is connected to a bleeder resistor, in this case present in the mri system was probably not connected.If the bleeder resistor was connected, the power in the quad hybrid would have been dissipated across the resistor and prevented the damage to the quad hybrid.Therefore, the cause of this defect and damage is leaving an unconnected tr coil inside the mri system while running the body coil in the transmit mode.From the information present, analysis performed, and from previous experience, the most probable cause of fault is operator error; the coil was left unconnected inside the mri system and the body coil was used to transmit power into the coil.This coil has been used against the instructions in the ifu and the user did not pay attention to the caution label present on the coil that warns the user of the burn hazard.It indicates that failure to remove this coil from the mr system when not plugged in may result in injury and/or damage to the coil.The device was originally manufactured according to its specification which included all designed safety features and is considered a safe and usable device, when used according to its intended use/indications for use.The product's risk file describes all hazards and risk controls accordingly.A review of the risk file indicates that normal operation will not cause parts to overheat.Components may locally warm up, but are enclosed in a rigid housing.Abnormally high power operation could cause parts to warm up to the point that the housing around the components gets too warm for patient contact.Leaving the coil unconnected is an operator error against the instructions in the ifu and product caution label.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: 1.5T QUADRATURE LOWER EXTREMITY COIL
• Type of Device: 1.5T QUADRATURE LOWER EXTREMITY COIL
• Manufacturer (Section D): INVIVO CORPORATION; 3545 sw 47th ave; gainesville FL 32608
• MDR Report Key: 9570027
• MDR Text Key: 198598836
• Report Number: 1056069-2020-00001
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K934396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9896-031-07421
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1